BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE(TM) SCREWDRIVER T15

    MDR report key: 8241866 · Received January 11, 2019

    Report

    Report Number
    2939274-2019-55803
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Report Date
    December 18, 2018
    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
    TX, 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 314.115. SYNTHES LOT # 5143327. SUPPLIER LOT # NA. RELEASE TO WAREHOUSE DATE: 09 JAN 2006. MANUFACTURED BY SYNTHES BRANDYWINE. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. NO 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. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE STARDRIVE SCREWDRIVER T15 (PART 314.115, LOT 5143327) WAS RETURNED TO US CUSTOMER QUALITY. UPON VISUAL INSPECTION, THE PHENOLIC HANDLE WAS FOUND TO BE BROKEN. IT WAS NOTED THAT THE BREAKAGE IN THE PHENOLIC HANDLE WAS RADIATING FROM THE DOWEL PIN. DISCOLORATION ALONG THE SCREW-DRIVER SHAFT AND THE DOWEL PIN WAS OBSERVED. MINOR SCRATCHES AND NICKS WERE OBSERVED AT THE DISTAL TIP OF THE SHAFT CONSISTENT WITH DEVICE USE. THE RETURNED CONDITION IS CONSISTENT WITH EXTENSIVE WEAR AND REPEATED STERILIZATION OF THE DEVICE OVER AN EXTENDED LIFETIME. THE HANDLE MATERIAL IS PHENOLIC LE GRADE WHICH IS SUSCEPTIBLE TO BECOMING BRITTLE AFTER BEING SUBJECTED TO YEARS OF THERMAL CYCLING WHICH ROUTINELY OCCURS DURING STERILIZATION CYCLES. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DOCUMENT REVIEW: THE RELEVANT DRAWINGS FOR THE DEVICE (TOP LEVEL) AND THE HANDLE (SUB-COMPONENT) WERE REVIEWED: UPON REVIEW OF THE DRAWINGS, IT WAS DETERMINED THAT THE RETURNED DEVICE WAS MADE TO SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT,ANY SUB-COMPONENTS, AND RAW MATERIALS WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON VISUAL INSPECTION, A CONCLUSIVE DETERMINATION HAS BEEN REACHED. THE DEVICE IS 13+ YEARS OLD (MANUFACTURED IN JANUARY 2006) THEREFORE THE DEVICE AGE IS LIKELY A CONTRIBUTING FACTOR. DIMENSIONAL ANALYSIS AROUND OTHER PARTS OF THE BROKEN HANDLE COULD NOT BE MEASURED ACCURATELY DUE TO POST MANUFACTURING DAMAGES. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE DEVICE WAS RECEIVED BROKEN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE UNDERWENT EXTENSIVE WEAR AND REPEATED STERILIZATION OVER AN EXTENDED LIFETIME. NO NEW MALFUNCTIONS WERE OBSERVED DURING THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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

    A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE HAS BEEN 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 ON AN UNKNOWN DATE, THE STARDRIVE SCREWDRIVER T15 WAS FOUND BROKEN IN THE WORKSTATION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER T15. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34063 STARDRIVE(TM) SCREWDRIVER T15 SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5143327 10886982188533

    Patients

    Seq Age Sex Outcome Treatment
    1