BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE

    MDR report key: 2962997 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-00171
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DHR WAS REVIEWED AND SOME NONCONFORMANCES WERE FOUND. DIM 11, A TIP DIAMETER, WAS UNDERSIZE. ONE HUNDRED PERCENT INSPECTION WAS PERFORMED ON THIS FEATURE 10 PARTS AND ONE PART WAS DISPOSITIONED AS SCRAP. DIM 12, EDGE BREAK ANGLE, WAS OVERSIZE. THIS CONDITION WAS ACCEPTED USE AS IS BY PRODUCT DEVELOPMENT. THE FEATURE IS INTENDED TO BREAK THE SHARP EDGE AND TO PROVIDE GUIDANCE AS THE DRIVER ENTERS THE SCREW. DIM 22, SHAFT DIAMETER WAS UNDERSIZE. THIS FEATURE WAS ACCEPTED USE AS IS BY PRODUCT DEVELOPMENT. THE FEATURE IS INTENDED TO MATE WITH THE HANDLE WHERE IT IS PINNED AND WELDED. THE RAW MATERIAL RECORDS WERE REVIEWED AND PASSED SPECIFICATIONS. ALL NON CONFORMANCES IDENTIFIED WERE DISPOSITION AS EITHER SCRAP, USE AS IS, OR REWORK. NO ISSUES IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW WOULD HAVE RELEVANCE TO THE COMPLAINT CONDITION. PART A: SINCE THE TIP WAS NOT RETURNED AND ALL OF THE FEATURES RELEVANT TO THE COMPLAINT CONDITION CANNOT BE MEASURED, THE COMPLAINT IS INDETERMINATE. PART B: SINCE THE TIP IS DAMAGED AND DEFORMED ACCURATE MEASUREMENTS CANNOT BE OBTAINED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PRODUCT DEVELOPMENT EVALUATED THE COMPLAINT: THE CAUSE OF THIS DRIVER BREAKAGE CANNOT BE FULLY DETERMINED GIVEN THE RETURNED CONDITION OF THE INSTRUMENT. LOADING BEYOND THE DESIGN BENCHMARK OF 11NM DUE TO EXTREMELY HARD PATIENT BONE, OFF AXIS LOADING, AND USE WITHOUT APPROPRIATE MATING INSTRUMENTS, HOLDING SLEEVE, AND OPTIONAL TAPS MAY HAVE CONTRIBUTED TO THE FAILURE OF THIS DRIVER. THE CHU REVIEWED THE RISK ANALYSIS FOR 03.607.001, SE 246643 AC. LINE 1340 ADEQUATELY ADDRESSES THE HAZARD OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    QUANTITY - 2 PARTS TOTAL. DATE RECEIVED BY MANUFACTURER, JANUARY, 25, 2013.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    DURING A POSTERIOR LUMBAR SURGERY, T10 TO PELVIS SURGEON NOTED PATIENT HAD HARD BONE. AS THE SURGEON WAS ATTEMPTING TO INSERT A SCREW, THE TIP OF THE SCREW DRIVER BROKE, THE TIP SHEARED OFF, AND THE SECOND TIP THAT WAS USED TWISTED AND BENT. THE SALES CONSULTANT OPENED ANOTHER SET AND THE SURGEON USED A DIFFERENT SCREW DRIVER AND THE THIRD ATTEMPT WENT IN FINE. THE PIECE WAS RETRIEVED WITHOUT AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68860 3.0MM BIHEXAGONAL SCREWDRIVER WITH T-HANDLE BIHEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE 6762228

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR