BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOPPER FOR LISS INSERTION GUIDES

    MDR report key: 8798055 · Received July 17, 2019

    Report

    Report Number
    2939274-2019-59231
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Report Date
    June 20, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982190932
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. INITIAL REPORTER IS A SYNTHES EMPLOYEE. PART: 324.019 (INTERNAL PART 42999); LOT: 9010785 (USED FOR FINISHED LOTS 2164875, 2152010, 2166002 OR 2148719); MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: APRIL 15, 2005. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBERS, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE STOPPER FOR LISS INSERTION GUIDES WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). A VISUAL INSPECTION WAS PERFORMED. IT WAS NOTICED THAT THE FLUTED TIP IS COMPLETELY BROKEN OFF AND THE BROKEN TIP WAS NOT RETURNED. THE REST OF THE DEVICE SHOWS SOME SURFACE WEAR AND NICKED. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE AND BROKEN PART NOT BEING RETURNED. MRE REVIEW: A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE STOPPER FOR LISS INSERTION GUIDES IS BROKEN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE BREAKAGE OF THE DEVICE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 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

    DEVICE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE STOPPER FOR LISS INSERTION GUIDES WAS DISCOVERED BROKEN. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. 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
    592296 STOPPER FOR LISS INSERTION GUIDES GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 324.019 9010785 10886982190932

    Patients

    Seq Age Sex Outcome Treatment
    1