BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION HANDLE

    MDR report key: 3111543 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01667
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING AN IMPACTION HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. A MATERIAL ANALYSIS CONCLUDED THAT NO MATERIAL OF MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. THE DEGRADATION OF THE HANDLES COULD BE DUE TO A WIDE RANGE OF CONDITIONS THAT CAN BE FOUND IN USE OVER TIME. NO SPECIFIC SET OF CONDITIONS COULD BE IDENTIFIED FOR THE DEGRADATION OBSERVED ON THESE RETURNED PARTS. NO PATIENT INFORMATION, PATIENT INVOLVEMENT, OR ADVERSE CONSEQUENCES WERE REPORTED. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT NO SPECIFIC SET OF CONDITIONS COULD BE IDENTIFIED FOR THE DEGRADATION OBSERVED ON THESE RETURNED PARTS.

    Description of Event or Problem · 1

    IT WAS REPROTED THAT THE PLASTIC COATING HAS COME LOOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC COATING HAS COME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211975 IMPACTION HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH N3V23

    Patients

    Seq Age Sex Outcome Treatment
    1 Other