BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHORAGE A0 TORQUE DRIVER

    MDR report key: 2364542 · Received December 2, 2011

    Report

    Report Number
    3004082045-2011-00078
    Event Type
    Malfunction
    Date Received
    December 2, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MEMOMETAL TECHNOLOGIES SA
    Product Code
    HTY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER LOT CODE INVOLVED IN THE EVENT IS C101089-10-00. SUMMARY OF EVALUATION: DIMENSIONAL INSPECTION WERE CONDUCTED ON SCREWDRIVERS AND SCREWS OF THE SAME RANGE AND HISTORICAL DATA WAS ANALYZED. DIMENSIONAL INSPECTION OF SCREWDRIVER AND SCREWS DETERMINED THAT THE SCREWDRIVER HEAD CAN BE OPTIMIZED. HISTORICAL DATA ANALYSIS DETERMINED THIS DIFFICULTY TO INTRODUCE THE SCREWDRIVER IN THE SCREW MAY HAPPEN. SCREWDRIVER HEAD DEFINITION HAS BEEN OPTIMIZED AND THE PIECES IN THE FIELD HAVE BEEN REPLACED ON CUSTOMER REQUEST. AS INSTRUCTED BY (B)(4) ON (B)(4) 2011, MDR REPORTED BY MEMOMETAL TECHNOLOGIES/(B)(4) AS A RESULT OF A RETROSPECTIVE LOOKBACK OF COMPLAINTS RESULTING FROM THE ACQUISITION OF MEMOMETAL TECHNOLOGIES BY STRYKER CORPORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO INSERT THE SCREW DRIVER INTO THE SCREW PRINT. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHORAGE A0 TORQUE DRIVER INSTRUMENT HTY MEMOMETAL TECHNOLOGIES SA NA C100344-10-00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other