BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE FOR CABLE CUTTER

    MDR report key: 12053840 · Received June 23, 2021

    Report

    Report Number
    2939274-2021-03187
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 4, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXZ
    UDI-DI
    10886982076717
    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:: REPORTER IS A J&J SALES REPRESENTATIVE. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE BLADE FOR CABLE CUTTER (P/N: 03.221.008, LOT #: T162927) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION THE PROXIMAL THREADS ON THE INNER BLADE ARE OBSERVED TO BE DEFORMED. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST CANNOT BE PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE BLADE FOR CABLE CUTTER (P/N: 03.221.008, LOT #: T162927). 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 DEFORMED. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 03.221.006 LOT NUMBER: T162927 MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: (B)(6) 2018. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 TOTAL HIP REPLACEMENT, THE CABLE CUTTER STOP CUTTING, GET STUCK AND WILL NOT CUT CABLES. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE PROXIMAL THREADS ON THE INNER BLADE ARE DEFORMED. THIS DEVICE CONDITION WAS DETERMINED TO BE REPORTABLE ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) BLADE FOR CABLE CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947059 BLADE FOR CABLE CUTTER CUTTER, WIRE HXZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.221.008 T162927 10886982076717

    Patients

    Seq Age Sex Outcome Treatment
    1