BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER

    MDR report key: 8511295 · Received April 12, 2019

    Report

    Report Number
    2939274-2019-57451
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Report Date
    March 20, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982076779
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART # 03.221.017 SYNTHES LOT # P220887 SUPPLIER LOT # P220887 RELEASE TO WAREHOUSE DATE: 08 SEP 2015; 05 OCT 2015; 16 OCT 2015 SUPPLIER: RTI SURGICAL NO NCR'S 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. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON AN UNKNOWN DATE, THE CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER WAS NOT FUNCTIONING PROPERLY. THE DEVICE IS FOR THE TABLE SET AND A FIELD INVENTORY. THE CABLE TENSIONER IS USELESS WITHOUT THE LOCKING MECHANISM OF THE CABLE LOCK IN ORDER TO USE THE TENSIONER ON THE TABLE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CABLE TENSIONER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304637 Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.221.017 P220887 10886982076779

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE EVENT DESCRIPTION