rapidsorb – resorbable tacks. resorbable fixation system.synthes.vo.llnwd.net/o16/mobile/synthes...

RapidSorb – Resorbable Tacks.Resorbable Fixation System.

Fast

Safe

Resorbable

Drill

Press

Fixed

Synthes 1

Table of Contents

Introduction

Surgical Technique

Product Information

Bibliography 12

Overview 2

Indications and Contraindications 4

RapidSorb 5

Insertion of Resorbable Tacks 6

Ordering Information 10

WarningThis description alone does not provide sufficient background for direct use ofthe product. Instruction by a surgeon experienced in handling this product ishighly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multi-part instruments,please refer to: www.synthes.com/reprocessing

2 Synthes RapidSorb – Resorbable Tacks

RapidSorb – Resorbable Tacks.Resorbable Fixation System.

Reliable fixation without tappingFast– No tapping– Quick push-in insertion– Automated tackdriver with adjustable insertion force

Safe– Retaining force is comparable with resorbable screws– Higher stability compared with wires or sutures– Push-out force remains for at least 8 weeks (see fig. 2 next

page).

Resorbable– Artifact-free on x-ray film and MRI diagnosis– No interference with radiotherapy – No implant migration or growth restriction – Resorption in about 1 year (RapidSorb) (see fig. 4 next

page)– Stability maintained during a minimum of 8 weeks during

critical bone-healing phase (see fig. 2 next page).

Drill Press Fixed

FastThe insertion of tacks allows a fast fixation of resorbableplates without the need of a threaded hole. This does notonly reduce the insertion time, but also allows an easier han-dling without the chance to turn off the screw head. The insertion is facilitated by the use of the automated tackdriverwhich allows the insertion of the tack by means of a loadedspring while just pressing a trigger.

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0 8 16 28 324 12 20 24 36 40

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In-vitro time, [weeks]

Push

-ou

t fo

rce,

[N

]

Synthes 3

Rem

ain

ing

imp

lan

t m

ass,

[%

]

[ Weeks]

Fig. 4: Remaining implant mass during decomposition degradation.

RapidSorb RapidSorb

Time in-vitro [ Weeks]

Fig. 3: Course of implant shear strength in percentage of initial strength duringdegradation.

Stre

ng

th r

eten

tio

n [

%]

Fig. 2: Course of push-out force tested under Laboratory conditions: Fixationremains for at least 8 weeks.

SafeThe resorbable implants are designed to maintain a stablefixation during the initial healing phase of the bone. Thepush out force is kept on a steady level for at least 8 weeksto keep the bone fragments and the plate in place. TheRapidSorb tack has a minimal shear force of about 70 N (ap-prox. 7 kg), which allows stable fixation of bone fragmentsin cranio-maxillofacial applications.

ResorbableAfter an initial strength retention phase for at least 8 weeksof the resorbable implants, the healed bone can take overthe function and the resorbable material is slowly degrading.

RapidSorb shows, due to its fast resorbing characteristics, anearly mass loss. The RapidSorb polymer is fully degraded inabout 1 year[3,4].

Fig.1


IndicationsThe Synthes RapidSorb resorbable plate, screw and tack sys-tems are used for bone fixation in the management of frac-tures or reconstructions of the craniofacial skeleton and asgraft containment, soft tissue fixation, and fixation implantsin other locations. The plates, screws and tacks should onlybe used in locations subject to low biomechanical loading,i.e. non-load bearing osteosynthesis exclusively.

Examples of appropriate indications include:– Trauma repair and reconstructive procedures in the mid fa-

cial area, maxilla and cranium.– Containment of bone grafts or bone graft substitutes in

other parts of the body in non-load bearing indications.

ContraindicationsThe Synthes RapidSorb Resorbable Fixation Systems shouldnot be used in the following circumstances:– Mandibular fractures subject to high biomechanical load-

ing– Resection of a mandibular tumor– Any fracture outside the area of craniofacial surgery with

load-bearing osteosynthesis situations– Synthes Resorbable Fixation Systems are not indicated for

use in load bearing and unstable indications for graft con-tainment, soft tissue fixation, and fixation implants unlessused in conjunction with appropriate osteosynthesis fixa-tion systems

– Blood supply limitations or reduced blood circulation– Insufficient quantity and quality of bone– Active, acute, latent, potential or chronic infections– Situations in which internal fixation is contraindicated for

other reasons, e.g. in patients with bone disorders or lackof willingness to cooperate (e.g. alcoholism)

– Foreign body sensitivity. Where material sensitivity is sus-pected, testing is to be completed prior to implantation

Indications and Contraindications

The implants are made of poly (L-lactide-co-glycolide) 85:15.The resorption time has been shown to be about 1 year[3,4].The implants have been designed to show minimal strengthretention of 60% for at least 8 weeks. RapidSorb plates havean improved design with feathered edges to reduce palpabil-ity, a longitudinal groove for topside identification, improvedcountersinks for a lower profile and a straight edge designfor higher strength. Compared to other fast degrading mate-rials, the RapidSorb polymer has been chosen to supportstrength retention for at least 8 weeks while keeping the ad-vantage of a fast degradation.

Synthes 5

RapidSorb


Surgical Technique

1

Select plates and tacks

Instruments

530.508 Water Bath System (230 V)

530.509 Water Bath System (115 V)

RapidSorb Implants

805.614.02S Tack � 1.5 mm, RapidSorb, length 4 mm, sterile, pack of 2 units



Select plates and tacks required for the corresponding indica-tion. If substantial plate bending is required, contour theplates using the Synthes Water Bath System.

2

Drill the first hole

Instruments

311.012 Handle, medium, with Mini Quick Coupling

310.177 Drill Bit � 1.5 mm with Stop, for ResorbableTacks, length 45/4 mm, for J-Latch Coupling

or310.182 Drill Bit � 1.5 mm with Stop, for Resorbable

Tacks, length 52/4 mm, for HexagonalCoupling

Drill the hole with the drill bit matching the diameter of the respective tack. A 1.5 mm tack with its 1.6 mm outer di-ameter and 1.3 mm core diameter is designed to anchor se-curely in a hole drilled with a � 1.5 mm drill bit.

� 1.5 mm � 1.6 mm

Synthes 7


Surgical Technique

3Pick up tack

Instrument

314.416 Tackdriver, self-holding, for Resorbable Tacksor 314.423 Tackdriver, automatic, self-holding

Self-holding tackdriver: Lightly press the tip of the tackdriveronto the tack; if the tack is not picked up immediately, gentlemovements back and forth will help anchor the tack securely.

4Insert the tack

Instrument

314.416 Tackdriver, self-holding, for Resorbable Tacksor 314.423 Tackdriver, automatic, self-holding

Insert the tack through the plate into the predrilled hole andfix with slight pressure. When using the tackdriver with theholding sleeve, the holding sleeve must be retracted beforethe tack is fixed completely. Place the first tack on the mobile fragment.

Repeat steps 2 to 4 for the other tacks.

Note: The insertion of the tacks requires the application of axial pressure which can lead to fragment shifting or, in extreme cases, to bone damage. Careful assessment of the indication is therefore essential, and a risk-benefit analysis must be performed by the surgeon in each case.

5Emergency fixation

Instruments


311.054–058 Tap for Resorbable Cortex Screws � 2 mm, self-drilling

314.686–687 Screwdriver Shaft 2.0, cruciform, with Holding Sleeve, for Mini Quick Coupling

For emergency fixation, the inserted tack and existing holecan be over-drilled by using a 2.0 mm self-drilling tap and a2.0 mm screw can be inserted.

Synthes 9


Instrument tray insert for tacks

184.829 Resorbable Tack System

309.905 Insert for Instrument Tray for Resorbable Tacks

309.906 Mini Module for Instrument Tray for Resorbable Tacks

Instruments


310.177 Drill Bit � 1.5 mm with Stop, for Resorbable Tacks, length 45/4 mm, for J-Latch Coupling

310.182 Drill Bit � 1.5 mm with Stop, for Resorbable Tacks, length 52/4 mm, for Hexagonal Coupling

314.416 Tackdriver, self-holding, for Resorbable Tacks

314.423 Tackdriver, automatic, self-holding

530.508 Water Bath System (230V)

530.509 Water Bath System (115V)

Instruments for Emergency Fixation


311.054–058 Tap for Resorbable Cortex Screws � 2 mm, self-drilling

314.686–687 Screwdriver Shaft 2.0, cruciform, with Holding Sleeve, for resorbable fixation system, for Mini Quick Coupling

Ordering Information

RapidSorb Implants




Synthes 11


1 Kleinsasser NH, Wild PJ, Perez Alvarez JC, et al. (2007)Extrusion forces of resorbable tacks and titianium screws inlaryngeal chondrosynthesis. Eur Arch Otorhinolaryngol264(4):409-413.

2 Al-Shukun J, Törnwall J, Lindqvist C, et al. (2006) Biore-sorbable Poly-L/DL-lactide (P[L/DL]LA 70/30) plates are reliable for repairing large inferior orbital wall bony defects:a pilot study. Am Assoc Oral Maxillofac Surg 64:47-55.

3 Landes CA, Ballon A, Roth C. (2006) In-patient versus invitro degradation of P(L/DL)LA and PLGA. J Biomed MaterRes B Appl Biomater 76B:403–411.

4 Landes CA, Ballon A, Roth C. (2006) Maxillary and mandi -bulary osteosyntheses with PLGA and P(L/DL)LA implants:a5-year inpatient biocompatibility and degradation experi-ence. Am Soc Plast Surg 117(7):2347-2360.

5 Landes CA, Kriener S, Menzer M, et al. (2003) Resorbableplate osteosynthesis of dislocated or pathological mandibu-lar fractures: a prospective clinical trial of two amorpohousL-/DL-Lactide Copolymer 2-mm Miniplate Systems. Am SocPlast Surg 111(2):601-610.

6 Landes CA, Kriener S, Menzer M. (2003) Resorbable plateosteosynthesis of sagittal split osteotomies with major bonemovement. Am Soc Plast Surg 111(6):1828-1840.

Bibliography

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All technique guides are available as PDF files at www.synthes.com/lit

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rapidsorb – resorbable tacks. resorbable fixation system.synthes.vo.llnwd.net/o16/mobile/synthes...

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