BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM LOCKING DEVICE

    MDR report key: 8704400 · Received June 17, 2019

    Report

    Report Number
    2939274-2019-58692
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 6, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982070319
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.037.015 (60082593). LOT: L925008 MANUFACTURING SITE: (B)(4) RELEASE TO WAREHOUSE DATE: 20.AUG.2018 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE AIMING ARM LOCKING DEVICE(PART # 03.037.015, LOT # L925008) WAS RETURNED AND RECEIVED AT US CQ. A VISUAL INSPECTION WAS PERFORMED. THE OUTER THREAD HAD A DEFORMATION WHICH CONFIRMS THE RECEIVED CONDITION AGREES WITH COMPLAINT CONDITION. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWING(S) WAS REVIEWED. THIS COMPLAINT IS CONFIRMED. CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THE DEFORMATION, IT IS POSSIBLE THAT THE CONDITION IS DUE TO CONSISTENT USE WITH POSSIBLE ROUGH HANDLING. 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

    THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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 THAT ON (B)(6) 2019, THE GUIDE SLEEVE ASSEMBLY WAS GETTING STUCK TO THE HELICAL BLADE INSERTER, MAKING THE INSTRUMENTATION NOT FUNCTION PROPERLY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. DURING MANUFACTURER'S INITIAL INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT AIMING ARM LOCKING DEVICE IS DEFORMED. THIS REPORT IS FOR ONE (1) AIMING ARM LOCKING DEVICE. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498426 AIMING ARM LOCKING DEVICE MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.015 L925008 10886982070319

    Patients

    Seq Age Sex Outcome Treatment
    1