BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCREWDRIVER BLADE, T7

    MDR report key: 1884830 · Received October 25, 2010

    Report

    Report Number
    8010177-2010-00375
    Event Type
    Other
    Date Received
    October 25, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 14, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    KIJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED PRODUCT NOT AVAILABLE TO STRYKER FOR INVESTIGATION. THE ROOT CAUSE IS ATTRIBUTED TO THE ROUNDED TORX PROFILES, ARE A MIX OF A USER ERROR AND A DESIGN RELATED ISSUE. TWO ACTIONS WERE RAISED BY R&D: TO ENSURE THAT THE WORST CASE IN THE TOLERANCES COULD NO LONGER OCCUR, A TIGHTER TOLERANCE FIELD WILL BE IMPLEMENTED SOON (BLADE AND SCREW). CHANGE REQUEST: (B)(4), IMPLEMENTED ACTIONS ON (B)(4) 2010. TO PROVIDE AN ALTERNATIVE TO THE FRICTION FIT A HOLDING SLEEVE SYSTEM WILL BE AVAILABLE SOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE SCREWDRIVER KEEP DISENGAGING FROM THE SCREW LIMITING THE SURGEON'S CONTROL OF DIRECTION OF THE SCREW." IT WAS ALSO REPORTED THAT THIS EVENT DELAYED SURGERY >30 MINUTES AND THAT ADDITIONAL ANESTHESIA WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREWDRIVER BLADE, T7 INSTRUMENT KIJ STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other