BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE(TM) SCREWDRIVER T15

    MDR report key: 8233497 · Received January 10, 2019

    Report

    Report Number
    2939274-2019-55769
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Report Date
    December 13, 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
    OR
    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, H6: PART: 314.115; SYNTHES LOT: 4972047; SUPPLIER LOT NA: RELEASE TO WAREHOUSE DATE: MARCH 30, 2005, MANUFACTURED BY SYNTHES BRANDYWINE NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. INVESTIGATION FLOWS: BROKEN & DAMAGE: VISUAL (APPEARANCE NOT AS EXPECTED) VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF A DAMAGED DRIVE HEAD, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. ONE DISTAL CORNER/EDGE OF THE SCREWDRIVER TIP HAS BROKEN OFF AND WAS NOT RETURNED AND THE ENTIRE DRIVE TIP SHOWS WEAR/WORN/STRIPPED EDGES. THE RECEIVED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION. DEVICE HISTORY RECORD (DHR) REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN MARCH 2005 AND IS OVER 13 YEARS OLD. NO NCRS 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. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING DESIGN DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION... TOP LEVEL T-15 SCREWDRIVER ASSEMBLY DESIGN DRAWING SCREWDRIVER SHAFT COMPONENT DESIGN DRAWING DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS ON THE BROKEN TIP COULD NOT BE OBTAINED DUE TO THE POST MANUFACTURING DAMAGE. THE SHAFT DIAMETER JUST PROXIMAL TO THE BROKEN TIP MEASURED Ø4.87MM AT CQ WHICH IS WITHIN SPECIFICATION OF Ø4.85±0.1MM. MATERIAL ANALYSIS: THE DESIGN SPECIFIED THE SCREWDRIVER SHAFT COMPONENT MATERIAL TO BE MANUFACTURED FROM X15TN MATERIAL AND HEAT TREATED PER ES0113. THE MATERIAL WAS REVIEWED, AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO (RELEVANT) NON-CONFORMANCE NOTED. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE TIP BREAKING COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. BECAUSE THE RETURNED DEVICE WHICH WAS MANUFACTURED IN 2005 FAILED AFTER 13 YEARS OF USE, IT IS DETERMINED THAT THE SUBSEQUENT MATERIAL CHANGE IN 2007 DID NOT CONTRIBUTE TO THIS COMPLAINT. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 BEEN 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE IN THE STERILE PROCESSING DEPARTMENT (SPD), THE STARDRIVE SCREWDRIVER WAS FOUND TO HAVE A DAMAGED DRIVE HEAD. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29355 STARDRIVE(TM) SCREWDRIVER T15 SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4972047 10886982188533

    Patients

    Seq Age Sex Outcome Treatment
    1