BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER DUO, SW 3.5 QUICK COUPLING

    MDR report key: 3905788 · Received May 28, 2014

    Report

    Report Number
    8043862-2014-00006
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 27, 2014
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIXHEAD OF THE SCREWDRIVER BROKE OF DURING INSERTION OF THE PLATE. THE PART WHICH BROKE OFF HAS BEEN NOT RETURNED TO THE MFR. THE SCREWDRIVER IS ABOUT TWO YEARS OLD. DEPENDING ON THE QUANTITY OF USAGES AND THE FORCES THAT APPLY A WEAR OUT COULD OCCUR AND A BREAKAGE IS THE RESULT. THE SCREWDRIVER SHOWED NO FURTHER DAMAGES.

    Description of Event or Problem · 1

    DRILL BIT BROKE OFF DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314836 SCREWDRIVER DUO, SW 3.5 QUICK COUPLING SCREWDRIVER HXX AAP IMPLANTATE AG IU 7835-65 I004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other