BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 7171601 · Received January 8, 2018

    Report

    Report Number
    2939274-2018-50107
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    November 2, 2017
    Report Date
    November 9, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982198204
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PART 391.201, LOT P153191: RELEASE TO WAREHOUSE DATE: JULY 08, 2013; AUGUST 02, 2013; AUGUST 15, 2013. SUPPLIER: (B)(6). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 391.201 WITH LOT NUMBER(S) P153191 IS A LOT/BATCH CONTROLLED ITEM. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE WAS NOT WORKING PROPERLY. THE REPAIR TECHNICIAN REPORTED THE CABLE WAS STUCK INSIDE THE TENSIONER. BINDING IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR. THE VENDOR REPORTED THE CABLE WAS JAMMED IN THE COLLET, AND THE SPRING REQUIRED LUBRICATION. THE VENDOR REPAIRED THE DEVICE PER THE VENDOR WORK INSTRUCTIONS. THE ITEM PASSED SYNTHES FINAL INSPECTION AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. 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 DURING AN UNKNOWN SURGERY ON (B)(6) 2017, IT WAS DISCOVERED THAT A SYNTHES CABLE TENSIONER WAS NOT WORKING PROPERLY. AN ALTERNATE DEVICE WAS IMMEDIATELY AVAILABLE AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO ADVERSE EVENTS WERE REPORTED AGAINST THE PATIENT. WHEN THE DEVICE WAS INSPECTED BY THE MANUFACTURER, IT WAS NOTED THAT REPORTED THE CABLE WAS STUCK INSIDE THE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16251 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE : SYNTHES USA PRODUCTS LLC P153191 10886982198204

    Patients

    Seq Age Sex Outcome Treatment
    1