BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 3070905 · Received April 22, 2013

    Report

    Report Number
    2530088-2013-10498
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    August 26, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 FEBRUARY 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.

    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 FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND, THE INVESTIGATION WAS UNABLE TO TEST THE HARDNESS OF THE MATERIAL. THE VISUAL INSPECTION REVEALED THE TIP IS BROKEN AS NOTED IN THE COMPLAINT. THE BREAK ON ONE SIDE STARTS APPROXIMATELY HALF WAY UP THE HEX TIP AND IS STRAIGHT ACROSS FOR HALF THE SHAFT DIAMETER. AT THAT POINT IT IS OBLIQUE UP TO A POINT ON THE OPPOSITE SIDE THAT IS THE FULL TIP LENGTH. THE TRANSITION FROM THE STRAIGHT ACROSS SURFACE TO THE FULL LENGTH TIP IS EVEN ON BOTH SIDES. THERE IS DEBRIS THROUGHOUT THE CANNULATION. THE PRODUCT EVALUATION DETERMINED OTHERWISE, THE SHAFT IS IN GOOD CONDITION THE DESIGN IS ACCEPTABLE. THIS DEVICE WAS RELEASED FOR SALE IN 1994 AND THIS SPECIFIC LOT WAS MANUFACTURED IN JANUARY 2003. THE DESIGN IS PROVEN AND THERE IS NO INDICATION OF A DESIGN RELATED ISSUE WITH THIS COMPLAINT. THE INVESTIGATION DETERMINED THIS EVENT TO BE INVALID.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    CONSULTANT REPORTED: DURING A FEMUR PROCEDURE, THE TIPS OF BOTH DRIVERS BROKE DURING THE PROCEDURE. PIECES BROKE INTO THE WOUND, BUT WERE RETRIEVED BY THE SURGEON. THE SURGEON USED A DRIVER FROM ANOTHER SET TO COMPLETE THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172702 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT HXX SYNTHES BRANDYWINE 4497345

    Patients

    Seq Age Sex Outcome Treatment
    1