BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER AXSOS T15 4.0MM LOCKING SET

    MDR report key: 3123684 · Received May 22, 2013

    Report

    Report Number
    0008031020-2013-00159
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    February 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE SCREWDRIVER TIP BROKE COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED BROKEN TIP WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE WAS CAUSED BY OVER TORQUE. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. 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. PLEASE NOTE THAT THE CURRENT OPTECH STATES: FINAL TIGHTENING OF LOCKING SCREWS SHOULD ALWAYS BE PERFORMED MANUALLY USING THE TORQUE LIMITING ATTACHMENT.

    Description of Event or Problem · 1

    TIP OF THE SCREWDRIVER BROKE WHEN INSERTING A AXSOS 4.0 LOCKING SCREW.

    Description of Event or Problem · 1

    TIP OF THE SCREWDRIVER BROKE WHEN INSERTING A AXSOS 4.0 LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226063 SCREWDRIVER AXSOS T15 4.0MM LOCKING SET INSTRUMENT LXH STRYKER TRAUMA SELZACH W13612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other