BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE(TM) SCREWDRIVER T15

    MDR report key: 8997602 · Received September 11, 2019

    Report

    Report Number
    2939274-2019-60475
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Report Date
    August 14, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188533
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. ADDITIONAL NARRATIVE: BACKGROUND: IT WAS REPORTED THAT DURING INSTRUMENT INSPECTION ON AUGUST 14, 2019, FOURTEEN (14) STARDRIVE SCREWDRIVER WERE FOUND TO BE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOURTEEN (14) DEVICES. INVESTIGATION FLOW: VISUAL/DAMAGE. VISUAL INSPECTION: THE STARDRIVE(TM) SCREWDRIVER T15 (P/N: 314.115 LOT: 4963227) WAS RECEIVED SHOWING THE DISTAL STARDRIVE TIP WORN AND STRIPPED. THE PHENOLIC HANDLE WAS WORN AND DARKENED. THE PHENOLIC HANDLE IS SUSCEPTIBLE TO BECOMING DARKENED AFTER REPEATED THERMAL/STERILIZATION/REPROCESSING CYCLES. THE STRIPPED DISTAL DRIVER TIP AND DARKENED HANDLE ARE POTENTIAL END OF LIFE INDICATORS OF THE INSTRUMENT FROM NORMAL WEAR, USE AND REPROCESSING. CONCLUSION: AFTER A VISUAL INSPECTION PER GUIDANCE PROVIDED IN WINDCHILL DOCUMENT#: (B)(4), 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. 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. A REVIEW OF THE DEVICE HISTORY RECORD: DEVICE HISTORY LOT: PART#: 314.115, SYNTHES LOT#: 4963227, SUPPLIER LOT#: NA, RELEASE TO WAREHOUSE DATE: 21 APR 2005, MANUFACTURED BY: SYNTHES BRANDYWINE, NO NCR'S WERE GENERATED DURING PRODUCTION. DEVICE HISTORY 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. LOT NUMBER PROVIDED FOR REPORTING. MANUFACTURE SITE PROVIDED. 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 NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: REPORTER IS SYNTHES SALES CONSULTANT. 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 DURING INSTRUMENT INSPECTION ON AUGUST 14, 2019, FOURTEEN (14) STAR DRIVE SCREWDRIVER WERE FOUND TO BE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STAR DRIVE SCREWDRIVER. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4). THIS COMPLAINT INVOLVES TOTAL 14 DEVICES. ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780953 STARDRIVE(TM) SCREWDRIVER T15 SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.115 4963227 10886982188533

    Patients

    Seq Age Sex Outcome Treatment
    1