BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER LOCKING INSERTER/EXTRACTOR

    MDR report key: 5185084 · Received October 28, 2015

    Report

    Report Number
    1822565-2015-02237
    Event Type
    Injury
    Date Received
    October 28, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 30, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    HWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS A MANUFACTURE DATE OF 6/21/1993 AND HAS A POTENTIAL SERVICE LIFE OF 22 YEARS. THE FEATURE ALLEGED AGAINST WAS ANALYZED DIMENSIONALLY AND/ OR VISUALLY. VISUAL EXAMINATION FOUND THAT ONE SCREW HAD FRACTURED. THE ALLEGED SHATTERED SPRING WAS NOT RETURNED. THIS DEVICE IS USED FOR TREATMENT. A PRODUCT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINT FOR THIS PART AND LOT COMBINATION. THE INSTRUMENT/PROVISIONAL USE, CARE, AND STERILIZATION PACKAGE INSERT WARNS NOT TO EXERT HIGH LOADS ON INSTRUMENTS AS THEY MAY BREAK, AND INSTRUCTS THE USER TO CHECK FOR DAMAGE BEFORE USE. THE LOCKING IMPACTOR/EXTRACTOR PACKAGE INSERT GIVES INFORMATION FOR USE INCLUDING HOW TO CORRECTLY SEAT OR REMOVE FEMORAL/TIBIAL IMPLANTS. IT ALSO WARNS NOT TO USE PRIMARY JAWS DURING A REVISION SURGERY BECAUSE THE EXTRACTION FORCE TO REMOVE A WELL-FIXED FEMORAL OR TIBIAL IMPLANT MAY EXCEED THE MECHANICAL STRENGTH OF THE PRIMARY JAWS. GIVEN THE AGE OF THIS INSTRUMENT, 22 YEARS IN THE FIELD, FAILURE IS MOST LIKELY A RESULT OF EXCEEDING ITS USEFUL LIFE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSTRUMENT FRACTURED DURING THE SURGERY. THE SCREW AND RETENTION SPRING PIECES WERE DISCOVERED IN THE PATIENT WITH FLUOROSCOPY AFTER THE INCISION WAS CLOSED UP WITH THE EXCEPTION OF THE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715985 ZIMMER LOCKING INSERTER/EXTRACTOR HWA HWA ZIMMER INC 48993600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention