BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER FOR SYNFIX(TM)-LR

    MDR report key: 3864095 · Received June 10, 2014

    Report

    Report Number
    9612488-2014-10209
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE INVOLVED IMPLANT HOLDER SHOWED NO SIGNS OF DAMAGE TO THE THREADS, AND WAS NOT BENT OR DISTORTED. THE REPORTED IMPLANT HOLDER DEVICE 03.802.039 IS PART OF THE SYNFIX-LR SYSTEM USED FOR STAND-ALONE ANTERIOR LUMBAR INTERBODY FUSION PROCEDURES. THE APPLICABLE TECHNIQUE GUIDE (REFERENCE #(B)(4)) WAS REVIEWED. ONCE THE ENDPLATE IS PREPARED AND IMPLANT SIZE IS DETERMINED, THE IMPLANT SIZE IS SELECTED AND PACKED INTO ITS CAVITIES WITH AUTOGRAFT MATERIAL AND THEN INSERTED USING AN IMPLANT HOLDER DEVICE. INSTRUCTIONS ARE PROVIDED FOR PROPER USE OF THE IMPLANT HOLDER, INCLUDING THE FOLLOWING RELATED INDICATION: ¿DO NOT CROSS THREAD THE IMPLANT HOLDER INTO THE IMPLANT. TO PREVENT CROSS THREADING, ENSURE THAT THE IMPLANT HOLDER IS PERPENDICULAR TO THE IMPLANT DURING ENGAGEMENT¿. THE SYSTEM ALSO INCLUDED THE OPTION TO INSERT THE IMPLANT USING A QUICK INSERTER DEVICE 03.802.121. THE REPORTED SYNFIX-LR IMPLANT 08.802.008S IS A PEEK SPACER WITH A TI-6AL-7NB PLATE AND A CANAL FOR GRAFTING. THREE IMPLANT HOLDERS (PART 03.802.039, LOT# 2328812(X2) MANUFACTURED JAN2008, AND LOT# 2727112 MANUFACTURED MAR2011) ALONG WITH ONE IMPLANT (08.802.008S, LOT 7733810) WERE RETURNED WITH THE COMPLAINT THAT THE IMPLANT HOLDER WAS CAUSING DAMAGE TO THE THREADS. UPON INSPECTION OF THE RETURNED DEVICES, THE INVOLVED IMPLANT HOLDERS SHOWED NO SIGNS OF DAMAGE TO THE THREADS, AND WERE NOT BENT OR DISTORTED. THE IMPLANT HOWEVER SHOWS SIGNS OF WEAR WHERE THE IMPLANT HOLDER INTERFACES WITH THE IMPLANT, AS WELL AS DAMAGE TO THE INTERNAL THREADING. THE CAUSE OF THIS COMPLAINT IS LIKELY THAT THE THREADING OF THE IMPLANT BECAME DAMAGED EARLY ON IN THE SURGERY DUE TO OFF AXIS APPLICATION, WHICH RESULTED IN IT NO LONGER BEING COMPATIBLE WITH THE GEOMETRY OF THE IMPLANT HOLDERS. THE APPLICABLE AND ASSOCIATED DRAWING ((B)(4)). THE DRAWING SE_074574 FOR THE INVOLVED SHAFT CALL OUT MATERIAL DIN 1.4923 STAINLESS STEEL, HOWEVER, THE CURRENT INTER-COMPANY DESIGN STANDARD ((B)(4)) HAS REMOVED THIS MATERIAL FROM THE APPROVED LIST AND MUST NOT BE USED ANYMORE FOR MEDICAL DEVICES. ADDITIONALLY, THIS INSTRUMENT HAS A REMOVABLE CAP, HOWEVER IT IS NOT CLEAR ITS FUNCTION AND IT IS IDENTIFIED THAT IF IT IS NOT FULLY THREADED IT MAY COMPROMISE THE IMPLANT THREAD ENGAGEMENT. IN CONCLUSION, IT IS LIKELY THE INITIAL INTERFACING WITH THE IMPLANT LED TO THE CROSS THREADING WHICH CONTRIBUTED TO CAUSING THIS COMPLAINT. THE DESIGN OF THESE DEVICES WAS FOUND TO BE ADEQUATE FOR THEIR APPLICATION AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYNFIX INSTRUMENT MALFUNCTIONED INTRAOPERATIVELY DURING A 2-LEVEL ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SURGEON IMPLANTED THE DEVICE WITH THE SYNFIX-LR SYNTHES QUICK INSERTED/DISTRACTOR (SQUID). ONCE THE SQUID WAS IMPLANTED, THE SURGEON ATTACHED THE IMPLANT HOLDER TO THE IMPLANT AND USED THE HOLDER TO CLAMP THE IMPLANT IN THE REMAINING COUPLE MILLIMETERS. THE SURGEON THEN REMOVED THE IMPLANT HOLDER DEVICE FROM THE IMPLANT AND TRIED TO ATTACH THE 12MM MINI OPEN AIMING DEVICE. WHEN ATTEMPTING TO ATTACH THE MINI OPENING AIMING DEVICE, THE DEVICES WOULD NOT THREAD AND THE SURGEON COULD HEAR A STRONG CROSS-THREADING METAL-METAL SCREECHING SOUND. IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO FULLY SEAT THE AIMING DEVICE AND HAD DIFFICULTY TRYING TO AWL THE INITIAL HOLES. THE SURGEON REMOVED THE AIMING DEVICE THEN REMOVED THE IMPLANT USING THE IMPLANT HOLDER. THE SURGEON THEN RE-PACKED A NEW IMPLANT WITH BONE GRAPH, AND INSERTED THE IMPLANT USING THE SQUID DEVICE. IT WAS REPORTED THAT THE SURGEON DID NOT USE THE IMPLANT HOLDER THE SECOND TIME BECAUSE HE FELT THAT THE IMPLANT HOLDER WAS CAUSING DAMAGE TO THE THREADS. THE SURGEON USED NEW SYNFIX MINI-OPEN IMPLANT COUPLINGS THE SECOND TIME. WHILE GOING THROUGH THE INSTRUMENTS DURING THE PROCEDURE, THE SALES CONSULTANT NOTED THAT TWO SPARE SYNFIX MINI-OPEN IMPLANT COUPLING INSTRUMENTS AND TWO SPARE SYNFIX-LR IMPLANT HOLDERS WERE DAMAGED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AS NORMAL WITH THE ABSENCE OF THE IMPLANT HOLDER. THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT AFTER THE PROCEDURE. THERE WAS A 20 MINUTE TIME DELAY DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS THE MAIN DEVICE THAT CROSS-THREADED DURING THE FIRST IMPLANT ATTEMPT. THIS DEVICE WAS NOT USED WHEN IMPLANTING THE SECOND DEVICE THIS IS REPORT 5 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338336 IMPLANT HOLDER FOR SYNFIX(TM)-LR MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 2328812

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR