BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 8207391 · Received January 1, 2019

    Report

    Report Number
    2939274-2019-55656
    Event Type
    Malfunction
    Date Received
    January 1, 2019
    Report Date
    December 27, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188922
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE 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

    DEVICE HISTORY LOT PART NUMBER: 314.467; SYNTHES LOT NUMBER: 5171921; RELEASE TO WAREHOUSE DATE: 11-MAY-2006; EXPIRATION DATE: N/A; MANUFACTURED BY SYNTHES (B)(4). REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY DEVICE EVALUATION: VISUAL INSPECTION: THE STARDRIVE SCREWDRIVER SHAFT T8 105MM (314.467) WAS RECEIVED WITH STRIPPED DISTAL LOBES. ADDITIONAL SURFACE WEAR CONSISTENT WITH USE WAS NOTED WHICH WOULD NOT IMPACT DEVICE FUNCTIONALITY. THE RECEIVED DEVICE MATCHES THE REPORTED CONDITION OF BENT, AS SUCH THE COMPLAINT IS CONFIRMED. THE DEVICE WAS FOUND DURING A SET INSPECTION, AS SUCH THE SPECIFIC CIRCUMSTANCES AT THE TIME OF THE ISSUE ARE UNKNOWN, THEREFORE, IT CANNOT BE DEFINITIVELY DETERMINED IF EXTERNAL FACTORS (USE ERROR, MISUSE/ABUSE, ETC.) IMPACTED THE COMPLAINT CONDITION. DIMENSIONAL INSPECTION: INSPECTION OF THE RELEVANT FEATURES, THE DISTAL TIP, WERE UNABLE TO BE COMPLETED DUE TO POST MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED AS THE DISTAL TIP OF THE SCREWDRIVER SHAFT WAS FOUND TO HAVE STRIPPED LOBES. AN ANALYSIS CODE OF VISUAL: STRIPPED/WORN/TWISTED/CROSS THREADED WAS SELECTED RATHER THAN THE REPORTED VISUAL: DEFORMED/BENT TO BETTER CAPTURE THE OBSERVED FAILURE. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION IS DUE TO THE APPLICATION OF EXCESSIVE FORCE OR A FAILURE TO FULLY SEAT THE TIP IN A SCREWS DRIVE RECESS DURING INSERTION/REMOVAL. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE INCOMING RECEIVING INSPECTION AT THE OWENS & MINOR FIELD STOCK LOCATION FACILITY, ON AN UNKNOWN DATE, A STARDRIVE SCREWDRIVER SHAFT WAS FOUND BENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 105MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120 STARDRIVE SCREWDRIVER SHAFT T8 105MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5171921 10886982188922

    Patients

    Seq Age Sex Outcome Treatment
    1