BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 55MM

    MDR report key: 8926480 · Received August 23, 2019

    Report

    Report Number
    2939274-2019-60037
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Report Date
    July 29, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188854
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 PERFORMED AT CUSTOMER QUALITY OBSERVED THAT THE DISTAL TIP OF STARDRIVE SCREWDRIVER SHAFT WAS WORN AND STRIPPED. THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION FOR STRIPPED AND IS THEREFORE CONFIRMED. THE RETURNED DEVICE SHOWED POTENTIAL END OF LIFE INDICATORS OF TWISTED AND STRIPPED INSERTION TIP FROM NORMAL WEAR AND USE OVER ITS LIFETIME (10+ YEARS). AFTER A VISUAL INSPECTION PER GUIDANCE PROVIDED IN WINDCHILL DOCUMENT # 0000277191, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT , PART: 314.453, LOT: 3120778, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 30.MAR.2009 . 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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, DURING A ROUTINE INSPECTION IN STERILE PROCESSING DEPARTMENT (SPD) THE SHORT STARDRIVE SCREWDRIVER SHAFT APPEARED TO BE DEFORMED. SPD REMOVED THE INSTRUMENT FROM THE SET, AND IT WAS REPLACED WITH A SUBSTITUTE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. WHEN THE DEVICE WAS BEING INVESTIGATED BY THE MANUFACTURER, IT WAS NOTED THAT THE DISTAL TIP OF STARDRIVE SCREWDRIVER SHAFT WAS WORN AND STRIPPED. THIS REPORT IS FOR A SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718917 STARDRIVE SCREWDRIVER SHAFT T8 55MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.453 3120778 10886982188854

    Patients

    Seq Age Sex Outcome Treatment
    1