BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER

    MDR report key: 11516016 · Received March 18, 2021

    Report

    Report Number
    2939274-2021-01393
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Report Date
    February 21, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXZ
    UDI-DI
    10886982080585
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CABLE CUTTER (P/N: 03.607.513, LOT NUMBER: L874573) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED A PIECE HAD BROKEN OFF ON THE JAW TIP. THIS COMPLAINT IS CONFIRMED AS THE JAW TIP HAS A PIECE BROKEN OFF. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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: 03.607.513. LOT NUMBER: L874573. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 22. MAY 2018 A MANUFACTURING RECORD EVALUATION 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 UNKNOWN DATE, THE CABLE CUTTER WERE FOUND IN SET TO BE BROKEN. THIS WAS DISCOVERED WHEN THEY OPENED THE SET FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE CUTTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418869 CABLE CUTTER CUTTER, WIRE HXZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.607.513 L874573 10886982080585

    Patients

    Seq Age Sex Outcome Treatment
    1