BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM

    MDR report key: 10818411 · Received November 10, 2020

    Report

    Report Number
    2939274-2020-05090
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 13, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982069641
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. VISUAL INSPECTION: THE SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM (PART #: 03.019.025, LOT #: L808316) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE CAP COMPONENT HAD BROKEN OFF OF THE PROXIMAL END OF THE LOCKING CORE SHAFT COMPONENT DUE TO THE BROKEN LASER WELD. THE BROKEN OFF CAP COMPONENT WAS RECEIVED AT US CQ. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: LOCKING CORE SHAFT DRAWING SPECIFIED DIMENSIONS: SHAFT OD, PROXIMAL END MEASURED DIMENSIONS: SHAFT OD, PROXIMAL END = CONFORMING DEVICE USED ¿ CALIPER CA 122P. CAP DRAWING: SPECIFIED DIMENSIONS: CAP SHAFT HOLE ID = MEASURED DIMENSIONS: CAP SHAFT HOLE ID = CONFORMING DEVICE USED ¿ CA 122P. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DOCUMENT(S) WERE REVIEWED: LOCKING CORE SHAFT: (CURRENT AND MANUFACTURED) CAP: SE_354053 REV B (CURRENT AND MANUFACTURED) LOCKING CORE KPL: (MANUFACTURED & CURRENT) SCREWDRIVER/ MULTILOC SCREW: (MANUFACTURED & OBSOLETED ON 10/11/2020) NO DESIGN ISSUES OR DISCREPANCIES WERE NOTICED. COMPLAINT CONFIRMED? YES . INVESTIGATION CONCLUSION THE COMPLAINT WAS CONFIRMED AS THE CAP COMPONENT HAD BROKEN OFF OF THE PROXIMAL END OF THE LOCKING CORE SHAFT COMPONENT DUE TO A BROKEN LASER WELD. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 HISTORY LOT PART: 03.019.025, LOT: L808316, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: JULY 12, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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) 2020, THE SCREWDRIVER FOR 4.5MM TITANIUM MULTILOC SCREWS SELF-RETAIN BROKE UPON ASSEMBLY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS NOT INVOLVED. THIS REPORT IS FOR ONE (1) SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279688 SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.019.025 L808316 10886982069641

    Patients

    Seq Age Sex Outcome Treatment
    1