BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC

    MDR report key: 10450005 · Received August 25, 2020

    Report

    Report Number
    2939274-2020-03789
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Report Date
    July 30, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10705034717784
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. H3, H4, H6- THE 10NM TORQUE LIMITING RATCHET HANDLE- 6MM HXC (P/N: 03.620.061, LOT #: 6458944-14) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, SLIGHT DISCOLORATION WAS OBSERVED ON THE DEVICE BUT WAS NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. THE COMPLAINT CONDITION WAS CONFIRMED FOR THE 10NM TORQUE LIMITING RATCHET HANDLE- 6MM HXC (P/N: 03.620.061, LOT #: 6458944-14). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART # 03.620.061, SYNTHES LOT # 6458944-14, SUPPLIER LOT # 6458944, RELEASE TO WAREHOUSE DATE: 01 DEC 2010, SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    ADDITIONAL NARRATIVE: INITIAL REPORTER IS SYNTHES EMPLOYEE THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 ON (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR, A 10NM TORQUE LIMITING RATCHET HANDLE-6MMM HXC FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913790 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.620.061 6458944-14 10705034717784

    Patients

    Seq Age Sex Outcome Treatment
    1