BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 8587853 · Received May 7, 2019

    Report

    Report Number
    8030965-2019-63595
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 7, 2019
    Report Date
    April 9, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819499188
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART: 03.010.523; LOT: 9890849; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: JULY 04, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. VISUAL INSPECTION: THE THREADED PART OF THE DRIVING CAP IS BROKEN OFF BELOW THE LAST THREAD FLANK. THE REMAINING THREAD FLANK IS TOTALLY FLATTENED, THE BLACK COATING IS NOT PRESENT ANYMORE AT THE DAMAGE. THE FRAGMENT OF THE THREADED PART IS STILL STUCK IN THE ALSO RECEIVED INSERTION HANDLE AND CANNOT BE REMOVED. IN GENERAL IS THE DRIVING CAP IN A VERY USED CONDITION THERE ARE NUMEROUS HAMMER MARKS ON TOP, WHICH CAN BE EXPECTED, BUT THERE ARE ALSO MANY HAMMER MARKS ON THE BOTTOM SIDE OF THE HEAD AND THE RIM BELOW THE HEXAGON. ALSO THERE ARE HAMMER MARK ON THE SIDE ABOVE THE HEXAGON. DIMENSIONAL INSPECTION: THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE DUE TO THE DAMAGE AT THE LAST THREAD FLANK AND AS THE FRAGMENT CANNOT BE REMOVED FROM THE INSERTION HANDLE. ACCORDING TO THE MANUFACTURING DOCUMENTS, THE M8 THREAD OF THIS LOT DID PASS ALL INSPECTION STEPS DURING MANUFACTURING WITHOUT ANY DEVIATIONS. MATERIAL/HARDNESS REVIEW: THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT THE CORRECT MATERIAL WAS USED AND THAT THE HARDNESS WAS WITH IN THE SPECIFICATION PER DRAWING. DRAWING/SPECIFICATION REVIEW: DRAWING REVIEWED FOR COMPARISON WITH THE MANUFACTURING DOCUMENTS. THE DEVICE IS USED FOR DIFFERENT SYSTEMS. EXPERT TIBIAL NAIL SURGICAL TECHNIQUE AND THE EXPERT LFN SURGICAL TECHNIQUE WERE REPRESENTATIVELY REVIEWED. IN BOTH CASES, THE DRIVING CAP IS USED FOR NAIL INSERTION; BOTH SURGICAL TECHNIQUES STATE: IF NECESSARY, USE LIGHT HAMMER BLOWS TO INSERT THE NAIL. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE DRIVING CAP IS BROKEN AS COMPLAINED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. ESPECIALLY THE HAMMER MARKS ON THE BOTTOM SIDE OF THE HEAD, THE RIM, AND ON THE SIDE ABOVE THE HEXAGON INDICATE THAT AN OFF-AXIS STRIKE ON THE DRIVING CAP DID LEAD OR CONTRIBUTE TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING A TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) IMPLANTATION FOR A PATIENT WITH A PROXIMAL FEMORAL FRACTURE, THE TFNA IMPACTOR/DRIVING CAP FOR INSERTION HANDLE WAS BROKEN INTO THE JIG INSERTION HANDLE/HYBRID INSERTION HANDLE. DURING IMPACTING AND HAMMERING THE INNER SCREW THREAD PART OF THE TIP OF THE IMPACTOR HAS SNAPPED OFF AND IS STILL IN AT THE BOTTOM THE JIG HANDLE HOLE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS GOOD. CONCOMITANT DEVICES REPORTED: HYBRID INSERTION HANDLE (PART# 03.037.011, LOT# 9881139, QUANTITY 1)UNKNOWN CONNECTING SCREW (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1) AND UNKNOWN HAMMER/MALLET (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRIVING CAP/ THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380005 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 9890849 07611819499188

    Patients

    Seq Age Sex Outcome Treatment
    1 HYBRID INSERTION HANDLE| UNK - IMPACTION INST: HAMMER/MALLET: TR| UNK - INSERTION INST: COUPLING SCREW: TR