BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC

    MDR report key: 10847009 · Received November 16, 2020

    Report

    Report Number
    2939274-2020-05175
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    January 1, 2020
    Report Date
    October 19, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982075192
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. H3, H4, H6: PART 03.130.010, LOT 9923514: RELEASE TO WAREHOUSE DATE: MAY 06, 2016. MANUFACTURED BY SYNTHES MONUMENT. NO NON-CONFORMANCE REPORTS (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. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, THE DISTAL TIP OF THE DEVICE WAS OBSERVED TO BE BROKEN AND THE BROKEN PORTION OF THE DEVICE WAS NOT RETURNED. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENT OF THE DEVICE. 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. BASED ON THE DATE OF MANUFACTURING, THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. THE COMPLAINT CONDITION WAS CONFIRMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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

    EVENT YEAR IS REPORTED AS 2020; HOWEVER EXACT DATE OF EVENT IS UNKNOWN. REPORTER IS JNJ REPRESENTATIVE. 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 AN UNKNOWN DATE, THE TIP OF THE STARDRIVE SCREWDRIVER SHAFT BROKE OFF. USED THE OTHER DRIVER IN THE SET. FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) STARDRIVE SCREWDRIVER SHAFT/T4 50MM/SELF-RETAINING/HXC. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313687 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.130.010 9923514 10886982075192

    Patients

    Seq Age Sex Outcome Treatment
    1