BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL IMPACTOR/EXTRACTOR

    MDR report key: 3140402 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01823
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY DISASSEMBLING THE TIBIAL IMPACTOR/EXTRACTOR FROM A TIBIAL TRAY WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION WAS PERFORMED AS PART OF MATERIAL ANALYSIS REPORT AND NOTED THAT LOCKING AND ENGAGEMENT MECHANISMS OF THE IMPACTOR/EXTRACTOR COULD BE EASILY ROTATED AND ARTICULATED. THE REPORTED FAILURE COULD NOT BE CONFIRMED. NO EVIDENCE OF ANY GALLING OR OTHER DAMAGE THAT COULD BE RESPONSIBLE FOR A LOSS OF FUNCTIONALITY WAS OBSERVED. FUNCTIONAL TESTING INDICATED THAT THE DEVICE WAS FUNCTIONALLY ACCEPTABLE. MATERIAL ANALYSIS CONCLUDED ¿THE RETURNED DEVICE FUNCTIONED AS EXPECTED. NO EVIDENCE OF ANY GALLING OR OTHER DAMAGE THAT COULD BE RESPONSIBLE FOR A LOSS OF FUNCTIONALITY WAS OBSERVED.¿ MEDICAL RECORDS WERE NOT REVIEWED FOR THIS INVESTIGATION AS THEY WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE MATERIAL ANALYSIS AND FUNCTIONAL INSPECTION INDICATE THAT THE EVENT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE TIBIAL HANDLE FAILURE TO RELEASE THE IMPLANT DURING IMPLANTING.

    Description of Event or Problem · 1

    THE TIBIAL HANDLE FAILURE TO RELEASE THE IMPLANT DURING IMPLANTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241917 TIBIAL IMPACTOR/EXTRACTOR INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other