BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG FEM ADPT TORQUE WRENCH

    MDR report key: 8355183 · Received February 20, 2019

    Report

    Report Number
    1818910-2019-85258
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    February 8, 2019
    Report Date
    February 8, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HXC
    UDI-DI
    10603295239789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED NON-FUNCTIONAL PROBLEM. THE BLACK PLASTIC PROTECTOR COMPONENT WAS LOOSE. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED NON-FUNCTIONAL PROBLEM. THE BLACK PLASTIC PROTECTOR COMPONENT WAS LOOSE. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE COMPLAINT SAMPLE CONSISTED OF (1) 961673 SIG FEM ADPT TORQUE WRENCH. EXAMINATION OF THE RETURNED DEVICE FOUND THE BLACK PLASTIC PROTECTOR COMPONENT WAS LOOSE AND STILL ATTACHED. THE LOOSE BLACK PLASTIC PROTECTOR COULD CONTRIBUTE TO THE REPORTED "INABILITY TO TIGHTEN THE IMPLANT". A SEARCH OF THE COMPLAINT DATABASE FOUND ADDITIONAL REPORTS OF CRACKING, LOOSE AND MISSING BLACK PLASTIC PROTECTOR. (B)(4) HAS BEEN INITIATED TO REMOVE THE RADEL® SOCKET CAP ALTOGETHER AND REPLACE WITH A TEFLON® (PTFE ¿ POLYTETRAFLUOROETHYLENE) SPLIT RING AND A PEEK (POLYETHERETHERKETONE) DISC TO THE TORQUE WRENCH. BASED ON A SIMILAR EVALUATION, THE ROOT CAUSE IS ATTRIBUTED TO THE DEVICE DESIGN. THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO RELEASE OF PRODUCTS MANUFACTURED TO (B)94). NO FURTHER CORRECTIVE ACTION REQUIRED. COMPLAINT TRENDS WILL BE MONITORED BY POST MARKET SURVEILLANCE THROUGH (B)(4). DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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

    THE BLACK PLASTIC PROTECTOR COMPONENT WAS LOOSE AND STILL ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147300 SIG FEM ADPT TORQUE WRENCH KNEE INSTRUMENT : TORQUE DEVICES HXC DEPUY ORTHOPAEDICS INC US A1107 10603295239789

    Patients

    Seq Age Sex Outcome Treatment
    1