BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO/ASIF QUICK COUPLING FOR DRILL BITS

    MDR report key: 3103017 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02144
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ORTHOPEDIC TRAUMA PROCEDURE ON (B)(6) 2013, THE CHUCK WORKED BUT EVENTUALLY BROKE DURING PROCEDURE. IN ADDITION TO THIS, A SCREWDRIVER SHAFT GOT STUCK IN THE QUICK COUPLING. IT WAS REPORTED THERE WAS NO DELAY OR ANY ADDITIONAL ISSUES WITH THE PROCEDURE, AND A ANOTHER SET WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR AO/ASIF QUICK COUPLING FOR DRILL BITS. THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203776 AO/ASIF QUICK COUPLING FOR DRILL BITS HWE SYNTHES GMBH 4966

    Patients

    Seq Age Sex Outcome Treatment
    1