BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFCSIG INS TRL CURVED 8MM SZ3

    MDR report key: 9720219 · Received February 18, 2020

    Report

    Report Number
    1818910-2020-05114
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    December 23, 2019
    Report Date
    February 11, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    UDI-DI
    10603295237228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY : EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRMED THE REPORTED EVENT, HOWEVER, ADDITIONAL DAMAGE WAS DISCOVERED. 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. DEVICE HISTORY LOT : NULL. DEVICE HISTORY BATCH : NULL. DEVICE HISTORY REVIEW : NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRMED THE REPORTED EVENT, HOWEVER, ADDITIONAL DAMAGE WAS DISCOVERED. 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. THE COMPLAINT SAMPLE CONSISTED OF (1) 961350 PFCSIG INS TRL CURVED 8MM SZ3. EXAMINATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED EVENT. THE INSTRUMENT WAS NOT BROKEN. IT WAS FOUND, HOWEVER, THAT THE INSTRUMENT HAD MULTIPLE SCRATCHES AND GOUGES. THE OVERALL CONDITION SUGGESTS HEAVY USAGE. THE ROOT CAUSE IS ATTRIBUTED TO WEAR FROM NORMAL USE AND SERVICING. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. MONITOR COMPLAINTS THROUGH (B)(4). DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. 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

    IT WAS REPORTED ON (B)(6) 2019 A SIZE 3 8MM FB SIGMA POLY TRIAL WAS BEING USED IN A CASE AND WAS DAMAGED AROUND THE BOTTOM WHEN THE LOCKING MECHANISM IS. FOLLOW-UP WITH THE SALES REPRESENTATIVE DETERMINED THAT IT WAS BROKEN ON THE BASE. THE BROKEN PART WAS THROWN AWAY. IT WAS BROKEN INTO TWO PARTS. NO PARTS REMAINED IN THE PATIENT. NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182635 PFCSIG INS TRL CURVED 8MM SZ3 KNEE INSTRUMENT : TIBIAL TRIALS LXH DEPUY ORTHOPAEDICS, INC. 1818910 96-1350 UNKNOWN 10603295237228

    Patients

    Seq Age Sex Outcome Treatment
    1