BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLA SET SCW HEXDRIVER

    MDR report key: 2972397 · Received February 21, 2013

    Report

    Report Number
    1526439-2013-12689
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION CONFIRMED THE HEX TIP OF THE DRIVER HAD BEEN SNAPPED OFF. REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. REVIEW OF PRODUCT COMPLAINTS FOUND NO EMERGING TRENDS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, THE OBSERVED DAMAGE SUGGESTS THAT THE DEVICE HEX TIP MOST LIKELY BROKE OFF DUE TO AN UNANTICIPATED TORSIONAL STRESS. IN THE ABSENCE OF AN OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT RETURNED LOAN KIT INSPECTION FOUND THE TIP OF THE SET SCREW HEX DRIVER HAD BROKEN OFF FROM THE INSTRUMENT. IT IS NOT KNOWN WHEN OR WHERE THE TIP BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76485 ISOLA SET SCW HEXDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1