BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER W/TRIGGER HANDLE

    MDR report key: 12415366 · Received September 2, 2021

    Report

    Report Number
    2939274-2021-05142
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 13, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXZ
    UDI-DI
    10886982076694
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PART NUMBER: 03.221.006. LOT NUMBER: T162927. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: NOVEMBER 9, 2018. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE CABLE CUTTER W/TRIGGER HANDLE (PART #: 03.221.006, LOT #: T162927) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THAT THE NOSE PIECE OF THE DEVICE, THE CUTTER WAS NOT RETURNED. ONLY THE TRIGGER WAS RETURNED. THERE WAS ONLY FOREIGN MATERIAL APPARENTLY A SPOT OF GLUE ON THE TRIGGER. NO OTHER DEFECT WAS OBSERVED FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS NOT PERFORMED WITH THE COMPLAINT DEVICE SINCE THE APPLICABLE MATING COMPONENTS (THE CUTTER AND THE CABLE) WERE NOT RETURNED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? UNABLE TO PERFORM DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED DUE TO REQUIRING DESTRUCTION OF THE DEVICE, AND DEVICE ASSEMBLY AND GEOMETRY LIMITS ABILITY TO ACCURATELY DIMENSIONALLY INSPECT DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE OVERALL COMPLAINT IS CONFIRMED AS THE COMPLAINT DEVICE WAS RETURNED MISSING ITS NOSE PIECE (CUTTER). HOWEVER, THE REPORTED ALLEGATION COULD NOT BE CONFIRMED AS FUNCTIONAL ASSESSMENT WAS NOT ABLE TO BE PERFORMED DUE TO MISSING CABLE AND THE NOSE PIECE. ONLY THE TRIGGER WAS RETURNED. THE FOREIGN MATERIAL OBSERVED DID NOT CONTRIBUTE IN ANYWAY TO THE COMPLAINT CONDITION. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY 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 THAT ON (B)(6) 2021, DURING A TOTAL HIP REPLACEMENT SURGERY THE CABLE GUN WOULD NOT CUT CABLE. THE TRIGGER WOULD NOT WORK. ANOTHER CUTTER WAS USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) CABLE CUTTER W/TRIGGER HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310311 CABLE CUTTER W/TRIGGER HANDLE CUTTER, WIRE HXZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.221.006 T162927 10886982076694

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR