BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATION SCREW T2 FEMUR

    MDR report key: 3092528 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00231
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED ISSUE WAS CONFIRMED. NO DEVIATIONS WERE FOUND IN THE MANUFACTURING DOCUMENTS. EVALUATION REVEALED THAT THE FOUND DAMAGED THREAD OF THE FIXATION SCREW WAS CAUSED BY CROSS-THREADING DUE TO AN OBLIQUE INSERTION IN COMBINATION WITH STRONG FORCES. THE ISSUE WAS NOT DEVICE RELATED BUT RATHER RELATED TO INADEQUATE OBLIQUE INSERTION OF THE FIXATION SCREW INTO A TARGET DEVICE. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW.

    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

    IT WAS REPORTED THAT THE SCREW COULDN`T BE LOCKED INTO THE TARGET DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW COULDN`T BE LOCKED INTO THE TARGET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193728 FIXATION SCREW T2 FEMUR INSTRUMENT HWC STRYKER OSTEOSYNTHESIS-KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other