BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER TI5, LENGTH 300MM

    MDR report key: 3003527 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10417
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 4, 2011
    Report Date
    May 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 FEBRUARY 2012. DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILLING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. PMA 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PRODUCT DEVELOPMENT REVIEW REPORTS THE SAMPLE WAS RETURNED WITH THE SCREW TIGHTENED DEEPLY INTO THE PLATE AND THE TIP OF THE SCREWDRIVER BROKE DUE TO EXCESSIVE FORCE APPLIED. MFG AND MATERIAL SHOW CONFORMITY TO THE SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON IMPLANTED THE SYNFIX IMPLANT AND SCREWS AND DECIDED TO MOVE THE IMPLANT. UPON MOVING, THE SURGEON EXPERIENCED TROUBLE REMOVING ONE SCREW AND THE TIP OF THE SCREWDRIVER BROKE OFF IN THE HEAD OF THE SCREW. THE SCREW AND THE IMPLANT WAS REMOVED. ANOTHER WAS SELECTED AND THE PROCEDURE COMPLETED. APPROXIMATELY 45 MINUTES WAS ADDED TO THE PROCEDURE. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86930 SCREWDRIVER TI5, LENGTH 300MM NONE HXX SYNTHES GMBH 3465722

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR