BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10NM TORQUE WRENCH 11MM ACROSS THE FLATS

    MDR report key: 11266235 · Received February 2, 2021

    Report

    Report Number
    2939274-2021-00612
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Report Date
    January 13, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXC
    UDI-DI
    10705034772233
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. H3, H6: INVESTIGATION SUMMARY: SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THAT THE DEVICE NEEDED TO BE RECALIBRATED. THE ITEM PASSED TESTING PER THE INSPECTION SHEET AND WORKED WITHIN NORMAL PARAMETERS. THE COMPLAINED ISSUE WAS NOT ABLE TO BE REPRODUCED. THE CAUSE OF THE COMPLAINED ISSUE IS UNKNOWN. THE ITEM PASSED SYNTHES FINAL INSPECTION ON JAN 25, 2021 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 30. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS UNCONFIRMED. DEVICE HISTORY LOT PART NUMBER: 388.261. SYNTHES LOT NUMBER: H812484. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: JUN 27, 2019. EXPIRATION DATE: N/A. SUPPLIER: (B)(4) MEDICAL PRODUCTS. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY 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 · 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. H10 ADDITIONAL NARRATIVE: D7, D9 E1 - PHONE NUMBER: THERE IS NO CONTACT INFORMATION AVAILABLE. E2, E3 G1, G4 H6 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. B5 D10: THERE ARE NO KNOWN CONCOMITANT DEVICES.

    Description of Event or Problem · 0

    THIS REPORT IS 1 OF 3 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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. 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) 2021, THAT TWO (2) TORQUE WRENCH NEED TO BE RECALIBRATED AND ONE (1) RIGID ARM NEEDS REPAIR. THE WRENCHES WERE TESTED AT THE OFFICE FOR FIT, FORM AND FUNCTION (FFF). THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER IN CONCOMITANT PRODUCT: 10NM TORQUE WRENCH 11MM ACROSS THE FLATS, (LOT & QTY UKN). THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) 10NM TORQUE WRENCH 11MM ACROSS THE FLATS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162032 10NM TORQUE WRENCH 11MM ACROSS THE FLATS WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 388.261 H812484 10705034772233

    Patients

    Seq Age Sex Outcome Treatment
    1 10NM TORQUE WRENCH 11MM ACROSS THE FLATS