BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING

    MDR report key: 9967759 · Received April 16, 2020

    Report

    Report Number
    2939274-2020-01875
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Report Date
    March 23, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10705034769110
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY SERVICE AND REPAIR EVALUATION: IT WAS REPORTED ON MARCH 23, 2020, DURING TESTING AT SERVICE AND REPAIR, THE TECHNICIAN FOUND OUT THAT THE TORQUE LIMITING HANDLE QUICK RELEASE HAS FAILED IN CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE REQUIRED FURTHER TESTING AT THE VENDOR. THE CAUSE OF THE ISSUE IS FAILED. THE VENDOR REPORTED THE DEVICE FAILED HIGH. THE ITEM WILL BE REPAIRED AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 21. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART # 321.133 SYNTHES LOT # 6553063 RELEASE TO WAREHOUSE DATE: MAR 10, 2011 SUPPLIER: TELEFLEX MEDICAL, INC. NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW DEVICE HISTORY REVIEWED. 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.

    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. H10 ADDITIONAL NARRATIVE: H3, H6: 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON (B)(6) 2020 DURING TESTING AT SERVICE AND REPAIR THE TECHNICIAN FOUND OUT THAT THE TORQUE LIMITING HANDLE QUICK RELEASE HAS FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431913 TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 321.133 10705034769110

    Patients

    Seq Age Sex Outcome Treatment
    1 TRQ LMTNG HNDL/QUK RLASE-6MM HX CUPLNG