BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMATCH HP KIT-3T/2.5F/L

    MDR report key: 5196054 · Received November 2, 2015

    Report

    Report Number
    1818910-2015-34276
    Event Type
    Malfunction
    Date Received
    November 2, 2015
    Date of Event
    September 25, 2015
    Report Date
    October 23, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED BLOCK CONFIRMED THE REPORTED BREAKAGE. A DESIGN FILE REVIEW CONFIRMED THE PROPOSAL DESIGN AND BLOCK DESIGN WERE DESIGNED WITHIN TRUMATCH SPECIFICATIONS. A DHR REVIEW WAS PERFORMED AND DISCREPANCIES DISCOVERED DURING THIS REVIEW. TWO NONCONFORMANCES WERE ASSOCIATED WITH THIS LOT: NR-0012936 AND NR-0013316. THESE NONCONFORMANCES WERE ASSOCIATED WITH CLEANING, NOT ASSEMBLY OR FUNCTIONALITY OF THE PART, AND THEREFORE ARE UNRELATED TO THIS COMPLAINT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE BREAKAGE. PER EMAIL FROM REP THE BLADE WAS A 1.19 MM THICKNESS BUT DID NOT CONFIRM IF IT WAS A WHALE TAIL OR NOT THAT WAS USED. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    TRUMATCH TIBIAL BLOCK PINNED, SAW CUT BEGAN, 1.19 BLADE, CUTTING GUIDE SHATTERED. UPDATE (B)(6) 2015: THE COMPLAINT SAMPLE TIBIAL CUTTING BLOCK WAS RECEIVED AND EXAMINATION CONFIRMS BREAKAGE IN ZONES 1 AND 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726356 TRUMATCH HP KIT-3T/2.5F/L KNEE INSTRUMENT/TRIAL NJL DEPUY ORTHOPAEDICS, INC. 1818910 062BB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR