BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADM BALL IMPACTOR TIP

    MDR report key: 2941859 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00547
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS DETERMINED TO BE USER RELATED. THE VISUAL INSPECTION AND MATERIAL ANALYSIS CONCLUDED THAT THE IMPACTOR TIP BROKE THROUGH THE THREADS AT APPROXIMATELY THE THIRD THREAD FROM THE MOUNTING SURFACE. MULTIPLE FRACTURE INITIATION SITES WERE OBSERVED ON THE FRACTURE SURFACE. THE FRACTURE PROGRESSED IN MULTIPLE DIRECTIONS. THE PART FAILED FROM MULTIPLE IMPACTS AS EVIDENCED BY THE ARREST LINES VISIBLE ON THE FRACTURE SURFACE. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE FRACTURE SURFACES EXAMINED. DEVICE HISTORY RECORDS FOR THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT THE BALL TIP GOT BROKEN DURING THE OPERATION. ANOTHER TIP WAS USED TO COMPLETE THE OPERATION. OPERATION GOT LONGER ONLY FEW MINUTES.

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT THE BALL TIP GOT BROKEN DURING THE OPERATION. ANOTHER TIP WAS USED TO COMPLETE THE OPERATION. OPERATION GOT LONGER ONLY FEW MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46347 ADM BALL IMPACTOR TIP INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3190596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other