BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMP HIP INSTRUMENT

    MDR report key: 5212206 · Received November 9, 2015

    Report

    Report Number
    1644408-2015-00667
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS COMPLAINT WAS THE THREAD BREAKING OFF IN THE SHELL. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS AVAILABLE TO DJO SURGICAL FOR EXAMINATION PM 11 DEC 2015. COMPLAINT DATABASE REVIEW SHOWED PREVIOUS COMPLAINTS BUT THERE WERE NO INDICATIONS THAT THIS INSTRUMENT HAS A DESIGN OR MATERIAL DEFICIENCY. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED THE PRODUCT WAS MANUFACTURED TO REVISION LEVEL SPECIFICATIONS. BASED ON THE RELEASED DATE THE POSITIONER, FMP ACET MAY HAVE BEEN IN SERVICE FOR OVER 2.4 YRS. EXAMINATION OF THE RETURNED POSITIONER, FMP ACET SHOWS THE THREADED TIP HAS BROKEN OFF. THE POSITIONER SHOULD BE SECURELY FASTENED TO THE FMP SHELL AND ENSURE THAT THERE IS NO GAP BETWEEN THE IMPACTING SLEEVE AND THE SHELL WHICH ARE SECURED TO EACH OTHER. IF A GAP EXISTS THE THREADED SECTION OF THE ACETABULAR INSERTER WILL BE SUBJECTED TO EXCESSIVE STRESS THAT COULD CAUSE THE THREADED SECTION TO BREAK, STRIP, OR AT LEAST FATIGUE OVER TIME. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE AS RECOMMENDED IN THE INSTRUMENT INSTRUCTIONS FOR USE 0400-0146 "RECOMMENDATIONS FOR THE CARE AND HANDLING FOR DJO SURGICAL INSTRUMENTS. CAPA-(B)(4) FOUND THE DESIGN OF THE FMP ACETABULAR POSITIONER COULD RESULT IN FRACTURE OF THE THREADED TIP WITH REPEATED USE . UNDER THE CAPA, THE INSTRUMENT HAS BEEN REDESIGNED AND GIVEN A NEW PART NUMBER. BASED ON THE PATIENT RISK LEVEL FROM THIS FAILURE MODE, IT WAS DECIDED TO TAKE NO ACTION ON EXISTING PART NUMBER 803-05-137 INSTRUMENTS IN THE FIELD AND IN INVENTORY. ROOT CAUSE FOR THIS EVENT IS ATTRIBUTABLE TO DAMAGE INCURRED FROM PROLONGED USE AND THROUGH MISUSE OR ROUGH HANDLING WHICH SURGICAL INSTRUMENTS ARE SUBJECTED TO. THIS IS NOT AN EVENT ASSOCIATED WITH A PRODUCT FAILURE, MALFUNCTION OR ISSUE.

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - WHILE THE SURGEON WAS REPLACING THE SHELL THE THREAD BROKE OFF IN THE SHELL. THE THREADED PART THAT INSERTS INTO THE CUP WAS BROKEN OFF AND REMAINED IN THE CUP IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741716 FMP HIP INSTRUMENT POSITIONER, FMP ACET HWA ENCORE MEDICAL, L.P. 06829L01

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR