BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIHEX Ø3 W/T-HANDLE

    MDR report key: 2923313 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00182
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 21, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE TIP OF THE SCREWDRIVER BROKE WHEN THE SURGEON WAS ATTEMPTING TO REMOVE A USS 2 POLYAXIAL SCREW. THE TIP OF THE DRIVER WAS EASILY LOCATED AND REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30357 SCREWDRIVER BIHEX Ø3 W/T-HANDLE SCREWDRIVER HXX SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1