BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR TRL RETAINING CLIP 28

    MDR report key: 10712579 · Received October 21, 2020

    Report

    Report Number
    1818910-2020-22970
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 7, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LXH
    UDI-DI
    10603295084501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE COMPLAINT. DEPUY-SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT#: (B)(4). (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOD ENDO TRIAL RETENTION CLIP HAD ISSUES HOLDING IN THE 28 HEAD BALL. SCRUB TECH, AND SURGEON BOTH SAID IT WAS LOOSE, AND THE 28 TRIAL KEPT FALLING OUT OF THE BIPOLAR TRIAL. CAUSED 2 TRIALS TO BE DROPPED ON THE GROUND DUE TO POOR RETENTION QUALITY. THIS WAS THE SECOND TIME THIS HAS HAPPENED. BOTH TIMES HAPPENED WITH A CLIP FROM THIS SAME LOT NUMBER. AFTER IT HAPPENED THE FIRST TIME, THE SALES REP CHECKED THE NEW CLIP BEFORE PUTTING IT IN THE SET. IT SEEMED TO FIT THE WAY IT SHOULD AT THAT POINT BUT THEN SOMEHOW SHRUNK OR CONTRACTED AFTER IT WAS STERILIZED. SALES REP HAD THE SCRUB TECH CHECK THE TENSION OF THE RING DURING SETUP OF CASE. AT THAT POINT SCRUB TECH AND SALES REP BOTH REALIZED THAT THE CLIP WAS LOOSE, AND NOT HOLDING PROPERLY. THE SURGEON WAS INFORMED OF THE MALFUNCTION BEFORE USING. LOOSENESS STILL CAUSED A BIPOLAR HEAD TO DISCONNECT, AND FALL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176262 BIPOLAR TRL RETAINING CLIP 28 HIP INSTRUMENTS : INSERTION DEVICES LXH DEPUY ORTHOPAEDICS INC US 2055-16-000 HW90342 10603295084501

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR