BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING

    MDR report key: 10252438 · Received July 9, 2020

    Report

    Report Number
    2939274-2020-03178
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Report Date
    June 26, 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

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. SERVICE AND REPAIR EVALUATION: IT WAS REPORTED ON JUNE 26, 2020, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED HIGH. THE CAUSE OF THE ISSUE IS FAILED HIGH. THE ITEM WILL BE REPAIRED AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER:321.133. SYNTHES LOT NUMBER: 6063251. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 12JAN2009. EXPIRATION DATE: N/A. SUPPLIER: (B)(4), INC.. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES 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
    713193 TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 321.133 6063251 10705034769110

    Patients

    Seq Age Sex Outcome Treatment
    1