BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIGGER HANDLE F/CABLE CUTTER

    MDR report key: 11135211 · Received January 7, 2021

    Report

    Report Number
    2939274-2021-00088
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 10, 2020
    Report Date
    December 10, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6- THE TRIGGER HANDLE F/CABLE CUTTER (P/N: 03.221.007, LOT #: T121360) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DEVICE WAS MISSING THE M4 SHOULDER BOLT COMPONENT. THE DEVICE WAS NOT OBSERVED TO BE BROKEN. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. THE COMPLAINT WAS CONFIRMED FOR THE TRIGGER HANDLE F/CABLE CUTTER (P/N: 03.221.007, LOT #: T121360) AS THE DEVICE WAS MISSING THE M4 SHOULDER NUT AND BOLT COMPONENTS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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 NUMBER: 03.221.007, LOT NUMBER: T121360, MANUFACTURING SITE: TUTTLINGEN, RELEASE TO WAREHOUSE DATE: 14-JUL-2015. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. 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 · 0

    THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    REPORTER IS A J&J SALES REPRESENTATIVE. THE DEVICE HAS BEEN 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 AN ORTHOPEDIC PROCEDURE OF THE PROXIMAL FEMUR A COLLINEAR CLAMP AND AN IMPACTOR HAD AN UNKNOWN ALLEGATION ALONG WITH THE TWO (2) BROKEN CUTTER. THERE WAS NO SURGICAL DELAY. A DIFFERENT SET WAS USED. THERE WERE NO FRAGMENTS GENERATED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM. THIS REPORT IS FOR ONE (1) TRIGGER HANDLE F/CABLE CUTTER THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32963 TRIGGER HANDLE F/CABLE CUTTER CUTTER,WIRE HXZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC T121360

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR