BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMP HIP INSTRUMENT

    MDR report key: 5085970 · Received September 17, 2015

    Report

    Report Number
    1644408-2015-00579
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LEFT IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS COMPLAINT WAS TO REPORT THE INSTRUMENT POSITIONER, FMP ACET THREADED TIP BREAKING OFF INTO THE IMPLANT DURING THE PRIMARY SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A 10 MINUTE DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE THREADED TIP WAS NOT RETURNED, AS NOTED "PATIENT RETAINS BROKEN PIECE FROM THE IMPACTOR, THE REST OF THE INSTRUMENT WAS RETURNED TO DJO SUGICAL ON 16 OCT 2015. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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 2.2 YRS. (B)(4). EXAMINATION OF THE RETURNED POSITIONER, FMP ACET CONFIRMED THE THREADED TIP (1/4-28-UNF-2A) HAS BROKEN OFF. THE THREADED TIP WAS NOT RETURNED, AS NOTED "PATIENT RETAINS BROKEN PIECE FROM THE IMPACTOR". THERE ARE MULTIPLE MARKS ON THE STRIKE PLATE FACE AND MARKS AND SCRATCHES ON THE REST OF THE INSTRUMENT. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR PERFORMANCE. REFER TO INSTRUMENT INSTRUCTIONS FOR USE (IFU) 0400-0146 "RECOMMENDATIONS FOR THE CARE AND HANDLING FOR DJO SURGICAL INSTRUMENTS. NO CONTAINMENT OF INVENTORY REQUIRED. CORRECTIVE AND PREVENTATIVE ACTION (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. NO FIELD ACTION WAS RECOMMENDED FOR THIS ISSUE. IF THE INSTRUMENT IS USED TO EXTRACT A SHELL THE SURGEON CAN HIT THE UNDERSIDE OF THE STRIKING FACE, WHICH CAN INTRODUCE BENDING LOAD RATHER A TYPICAL AXIAL LOAD. SUCH A LOAD CAN EXCEED THE DESIGN CAPABILITIES OF THE THREADED TIP CAUSING IT TO FRACTURE. EVEN IF THE FAILURE DID NOT OCCUR IMMEDIATELY FROM THE BENDING LOADS, A SMALL AMOUNT OF DAMAGE COULD HAVE BEEN INTRODUCED WHICH SLOWLY EXPANDED AND EVENTUALLY FAILED AT A LATER TIME. THE SURGEON IS RESPONSIBLE TO ENSURE THAT THE ACETABULAR POSITIONER IS SECURELY FASTENED TO THE FMP SHELL AND 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. SURGICAL INSTRUMENTS CONDITION CAN BE DETERMINED WHILE BEING USED FOR ITS INTENDED PURPOSE. THE REPLACEMENT OF SURGICAL INSTRUMENTS DUE TO NORMAL WEAR AND TEAR DOES NOT INDICATE A PRODUCT DEFICIENCY, FAILURE OR ISSUE. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THE ROOT CAUSE OF THE EVENT IS THAT AN AREA OF LOCALIZED STRESS CONCENTRATION EXISTS IN THE TIP DESIGN OF THE FMP ACETABULAR POSITIONER. OTHER POTENTIAL CAUSES FOR THIS EVENT INCLUDE MISALIGNMENT OF THE INSTRUMENT DURING IMPACTION, OR REPEATED IMPACT LOADS, TORSIONAL LOADS, AND BENDING LOADS APPLIED AT THE INTERFACE WITH THE ACETABULAR IMPLANT.

    Description of Event or Problem · 1

    PRIMARY SURGERY/INSTRUMENT FAILURE - THE PATIENT WAS HAVING A TOTAL HIP REPLACEMENT. AT THE TIME WHEN THE ACETABULAR CUP WAS BEING IMPLANTED WITH THE IMPACTOR, THE SCREW THAT ATTACHES THE 2 PIECES BROKE OFF INSIDE THE IMPLANT IN THE PATIENT. THE PATIENT RETAINS THE BROKEN PIECE FROM THE IMPACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616903 FMP HIP INSTRUMENT POSITIONER, FMP ACET LXH ENCORE MEDICAL, L.P. 106829L01

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR