BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10779459 · Received November 3, 2020

    Report

    Report Number
    2939274-2020-04953
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 7, 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
    NV, 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. VISUAL INSPECTION: THE SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM WAS RETURNED AND RECEIVED AT US CQ. ONLY LOCKING CORE (03.019.025.01, UNKNOWN LOT) WAS RECEIVED AT CQ. UPON VISUAL INSPECTION AT CQ, IT WAS OBSERVED THAT THE LASER WELD ATTACHING CORE SHAFT AND CAP. THE REST OF THE DEVICE SHOWS NORMAL WEAR CONSISTENT WITH THE DEVICE USE WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: THE OUTER DIAMETER OF THE SHAFT NEAR LASER WELD WAS MEASURED TO BE WITHIN THE SPECIFICATION AS PER THE DRAWING. THE INTERNAL DIAMETER OF THE CAP WAS MEASURED TO BE WITHIN THE SPECIFICATION. MEASURING DEVICES USED: CA122P. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWINGS WERE REVIEWED -LOCKING CORE KPL -CAP -LOCKING CORE SHAFT -SCREWDRIVER/ MULTILOC SCREW -GENERAL TOLERANCES_SE NO DESIGN ISSUES OR DISCREPANCIES WERE NOTICED. COMPLAINT CONFIRMED? YES . INVESTIGATION CONCLUSION THE COMPLAINT CONDITION WAS CONFIRMED FOR THE SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM (PART. NO: 03.019.025, LOT. NO: UNKNOWN). THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IT IS POSSIBLE THAT THE DEVICE MIGHT HAVE ENCOUNTERED UNINTENDED FORCES. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES, OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED UPON THESE RESULTS, 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. THEREFORE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE 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

    REPORTER IS JNJ REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE DEVICE WAS 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) 2020, THE TIP OF THE SCREWDRIVER FOR MULTILOC SCREWS WAS BROKEN. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. PATIENT NOR PROCEDURE INVOLVEMENT WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) SCREWDRIVER 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
    1244599 SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.019.025 10886982069641

    Patients

    Seq Age Sex Outcome Treatment
    1