BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG SCALPEL HANDLE

    MDR report key: 11871858 · Received May 24, 2021

    Report

    Report Number
    2939274-2021-02525
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Report Date
    April 27, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GDZ
    UDI-DI
    10886982069085
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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 # 03.010.491 SYNTHES LOT#: H649115 SUPPLIER LOT # H649115 RELEASE TO WAREHOUSE DATE: OCTOBER 25, 2018 SUPPLIER: AVALIGN TECHNOLOGIES-NEMCOMED 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. VISUAL INSPECTION: THE LONG SCALPEL HANDLE (PART #: 03.010.491, LOT #: H649115) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE SCALPEL TIP BROKE OFF AND THE BROKEN PIECE WAS NOT RETURNED. NO OTHER DEFECTS WERE OBSERVED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: AN ACCURATE DIMENSIONAL INSPECTION WAS NOT ABLE TO BE PERFORMED BECAUSE THE BREAK OCCURRED AT A RADIUSED TRANSITION. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWING(S) WAS REVIEWED; - SCALPEL ASSEMBLY - SCALPEL TIP COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THIS COMPLAINT WAS CONFIRMED AS THE SCALPEL TIP BROKE OFF OF THE COMPLAINT DEVICE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING ITS USE. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    PRODUCT COMPLAINT (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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 UNKNOWN DATE, THE KNIFE HANDLE WAS FOUND BROKEN WHILE ASSEMBLING THE SET. THE KNIFE HANDLE WAS NO USED DURING THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766667 LONG SCALPEL HANDLE HANDLE, SCALPEL GDZ WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.491 H649115 10886982069085

    Patients

    Seq Age Sex Outcome Treatment
    1