BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING

    MDR report key: 8081608 · Received November 16, 2018

    Report

    Report Number
    2939274-2018-55016
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Report Date
    October 31, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982067821
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 03.010.110, LOT: 6060698. MANUFACTURING LOCATION: BRANDYWINE, MANUFACTURING DATE: JAN 08, 2009. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. THE MATERIAL WAS REVIEWED AND THE HARDNESS VALUE WAS CONFIRMED TO MEET THE SPECIFICATION WITH NO RELEVANT NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) IDENTIFIED THE CONDITION OF A MALFORMED DISTAL STARDRIVE TIP, WHICH DOES NOT AGREE WITH THE REPORTED COMPLAINT CONDITION OF A BROKEN SCREWDRIVER. THE DISTAL EDGES OF THE STARDRIVE TIP ARE MALFORMED, BUT NO FRAGMENTS ARE MISSING. THE HANDLE IS INTACT WITH NO DAMAGE. THEREFORE THIS COMPLAINT IS CONFIRMED FOR POST MANUFACTURING DAMAGE/DEFORMATION OF THE SHAFT TIP BUT NOT CONFIRMED FOR THE REPORTED CONDITION OF BREAKAGE. RECEIVED CONDITION DOES NOT AGREE WITH COMPLAINT DESCRIPTION AS THE REPORTED CONDITION IS BROKE AND RECEIVED CONDITION IS MALFORMED. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DESIGN DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION OF THE STARDRIVE FEATURE COULD NOT BE OBTAINED DUE TO THE DEFORMATION. THE INSIDE DIAMETER AT THE DAMAGED DISTAL STAR DRIVE TIP MEASURED Ø3.30MM AT CQ (GP29) WHICH IS WITHIN SPECIFICATION OF Ø3.3MM +0.1/-0MM PER SHAFT COMPONENT DESIGN DRAWING. THE SHAFT OUTSIDE DIAMETER JUST PROXIMAL TO THE DAMAGED DISTAL STAR DRIVE TIP MEASURED Ø7.49MM AT CQ (CALIPERS CA215P) WHICH IS WITHIN SPECIFICATION OF Ø7.5MM +/-0.1MM PER SHAFT COMPONENT DESIGN DRAWING. THE OVERALL LENGTH OF THE RETURNED SCREWDRIVER MEASURED 299.84MM AT CQ (CALIPERS CA472) WHICH IS WITHIN SPECIFICATION OF Ø300MM +/-2.0MM. MATERIAL ANALYSIS: THE DESIGN SPECIFIED THAT SHAFT TO BE MANUFACTURED FROM 1.4028 (465 PH MATERIAL) AND HEAT TREATED. 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 POST MANUFACTURING DEFORMATION ON THE RETURNED 9 YEAR OLD REUSABLE SCREWDRIVER COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, IT WAS FOUND OUT THAT DURING INSPECTION, THE SCREWDRIVER WAS BROKEN. THERE WAS 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
    918475 CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6060698 10886982067821

    Patients

    Seq Age Sex Outcome Treatment
    1