BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CUTTER

    MDR report key: 10555465 · Received September 18, 2020

    Report

    Report Number
    2939274-2020-04214
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Report Date
    September 17, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXZ
    UDI-DI
    07611819710504
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE ROD CUTTER DOES NOT FUNCTION. THE REPAIR TECHNICIAN REPORTED THE DEVICE JAWS ARE DAMAGED. CUTTING JAWS ARE BROKEN IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: JAW, BOLT SYSTEM. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON (B)(6) 2020 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. FINALIZED SERVICE RECORD WILL BE ARCHIVED IN TUNGSTEN DOCUMENT MANAGEMENT SYSTEM. THE EVALUATION WAS CONFIRMED. THE DEVICE WAS DEEMED SERVICEABLE AND WILL BE RETURNED TO THE CUSTOMER, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED THEREFORE IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART NUMBER: 388.720, LOT NUMBER: T112808, MANUFACTURING SITE: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S 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 AN UNKNOWN DATE, THE ROD CUTTER JAWS DID NOT FUNCTION. IT WAS DISCOVERED BY THE TECHNICIANS DURING AN INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ROD CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019984 ROD CUTTER CUTTER, WIRE HXZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC T112808 07611819710504

    Patients

    Seq Age Sex Outcome Treatment
    1