BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER HEX 2.5MM AO FITTING

    MDR report key: 2971405 · Received February 21, 2013

    Report

    Report Number
    0008031020-2013-00019
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE AFFECTED DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE LOOKS WORN DOWN FROM USE. THE AFFECTED DEVICE WAS SENT TO THE MANUFACTURING CELL FOR DIMENSIONAL AND FUNCTIONAL INSPECTION. RESULTS SHOW THE DEVICE IS OUT OF SPECIFICATION DUE TO THE FACT IT WAS USED MULTIPLE TIMES. THE AO COUPLING IS ALSO DAMAGED. THEREFORE, THE REPORTED EVENT THAT THE SCREWDRIVER SLIPS IN THE SCREW HEAD COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED DAMAGE WAS ATTRIBUTED TO A USE RELATED ISSUE (WEAR AND TEAR). THE DEVICE WAS MANUFACTURED MORE THAN 3 YEARS AGO. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    2.5 HEX SCREWDRIVERS IN MATTA PELVIC BASIC INSTRUMENTS ARE WORN DOWN FROM USE AND CAUSED SCREWDRIVERS TO SLIP IN SCREW HEAD WHILE TURNING.

    Description of Event or Problem · 1

    2.5 HEX SCREWDRIVERS IN MATTA PELVIC BASIC INSTRUMENTS ARE WORN DOWN FROM USE AND CAUSED SCREWDRIVERS TO SLIP IN SCREW HEAD WHILE TURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77037 SCREWDRIVER HEX 2.5MM AO FITTING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other