BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA TC3 FE BX TRL/SZ 4

    MDR report key: 5979324 · Received September 27, 2016

    Report

    Report Number
    1818910-2016-28115
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 14, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. (B)(4).

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

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: EXAMINATION OF THE SUBMITTED SCREWDRIVER FOUND THE HEX TIPS EXHIBITING WEAR. THE SCREWDRIVER HAS BEEN SUBJECTED TO HEAVY USAGE AND HAS WORN OUT DUE TO NORMAL USE AND SERVICING. THE ROOT CAUSE IS ATTRIBUTED TO DEVICE WEAR FROM NORMAL USE AND SERVICING. BASED ON THE DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING AS THE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. EXAMINATION OF THE RETURNED 961054 PFC*SIGMA TC3 FE BX TRL/SZ4 CONFIRMS THAT THE SET SCREW IS STUCK. WEAR AND TEAR IS EVIDENT. THE ROOT CAUSE IS ATTRIBUTED TO DEVICE WEAR FROM NORMAL USE AND SERVICING. THE DEVICE HAS BEEN SUBJECTED TO HEAVY USAGE AND IS WORN OUT. BASED ON THE ROOT DETERMINATION OF DEVICE WEAR FROM NORMAL USE AND SERVICING, 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.

    Description of Event or Problem · 1

    WHEN THE NURSE ASSEMBLED THE BOX-TRIAL TC3: (THE EQUIPMENT OF FEMORAL TRIAL-SIZE 4), THE SCREW DIDN'T ROUND AT ALL. THE NURSE ASKED THE SURGEON TO ROUND THE SCREW, BUT ALSO THE SCREW DIDN'T ROUND AT ALL. THEN BOTH BOX-TRIAL TC3 AND TRIAL-BOX SCREWDRIVER GOT BROKEN. THE SURGERY WAS PERFORMED SUCCESSFULLY WITH FEMORAL TRIAL-SIZE 2.5 AND AO SMALL DRIVER INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630866 PFC*SIGMA TC3 FE BX TRL/SZ 4 KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. J1105

    Patients

    Seq Age Sex Outcome Treatment
    1