BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLA SET SCW HEXDRIVER

    MDR report key: 3072492 · Received April 23, 2013

    Report

    Report Number
    1526439-2013-15719
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 24, 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

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

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION NOTED THAT HEX TIP OF THE DRIVER HAD SNAPPED OFF FROM THE INSTRUMENT. THE BROKEN HEX TIP SECTION WAS NOT RETURNED FOR FURTHER EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, THE NOTED DAMAGE SUGGESTS THAT THE DEVICE HEX TIP MOST LIKELY BROKE OFF DUE TO AN UNANTICIPATED TORSIONAL STRESS. IN THE ABSENCE OF A PRODUCT ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT INSPECTION OF A RETURNED LOANER KIT FOUND THE TIP OF THE HEX DRIVER HAD BROKEN OFF FROM THE INSTRUMENT. IT IS NOT KNOWN WHEN/WHERE TIP BREAKAGE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173230 ISOLA SET SCW HEXDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1