BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX STARDRIVE SCREWDRIVER

    MDR report key: 3003361 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10406
    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

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO 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 NONCONFORMANCE RELATED TO THIS COMPLAINT WERE FOUND. FIVE (5) SMALL BROWN STAINS (APPROX 1MM IN DIAMETER), WERE OBSERVED ON THE LARGE DIAMETER OF THE SHAFT NEAREST THE TIP. THESE STAINS WERE NOT A RESULT OF THE MFG PROCESS. THE STAINS COULD NOT BE REMOVED DURING THIS EVAL USING A PRE-MOISTENED ALCOHOL WIPE. THE TIP OF INSTRUMENT SHOWED MINIMAL WEAR. THE INDIVIDUAL STERILE PEEL PACKAGE WITH BROWN STAINS REFERENCED IN THE COMPLAINT DESCRIPTION WAS NOT RETURNED FOR INVESTIGATION. MOREOVER, THE MFG SITE DID NOT PACKAGE THIS INSTRUMENT IN STERILE PEEL PACKAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE STERILIZATION OF SCREWDRIVERS IN THEIR INDIVIDUAL PEAL PACKAGE, THERE WAS A BROWN STAIN LEFT ON ALL OF THE SCREWDRIVERS. THE STERILIZATION WAS CALLED INTO QUESTION BY THE HOSPITAL. NO PROCEDURE WAS EFFECTED AND NO ADVERSE EFFECT TO PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86952 HEX STARDRIVE SCREWDRIVER HXX SYNTHES GMBH 5106907

    Patients

    Seq Age Sex Outcome Treatment
    1