BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE HEXAGONAL SCREWDRIVER

    MDR report key: 3003359 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10405
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    May 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED 02/2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO NONCONFORMANCES RELATED TO THIS COMPLAINT WERE FOUND. IT WAS OBSERVED THAT THE HANDLES OF THE SUBJECT DEVICE WERE BLEACHED AND CRACKED. BLEEDING OUT OF THE PLASTIC CANVAS IT IS A WELL KNOWN PHENOMENON AFTER A LONG PERIOD OF REPEATED STERILIZATION PROCESSES AT HIGH TEMPERATURES. WE CLASSIFY THIS TO BE NORMAL WEAR AND TEAR, AS THESE ARE INSTRUMENTS THAT ARE USED OFTEN AND INTENSELY. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STERILIZATION OF SCREWDRIVERS IN THEIR INDIVIDUAL PEEL PACKAGE, THERE WAS A BROWN STAIN LEFT ON ALL THE SCREWDRIVERS. THE STERILIZATION WAS CALLED INTO QUESTION BY THE HOSPITAL. NO PROCEDURE WAS EFFECTED AND NO ADVERSE EFFECT TO PTS WAS REPORTED. THIS REPORT IS 4 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86589 LARGE HEXAGONAL SCREWDRIVER HXX SYNTHES GMBH 4284193

    Patients

    Seq Age Sex Outcome Treatment
    1