BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 7606307 · Received June 15, 2018

    Report

    Report Number
    2939274-2018-52512
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Report Date
    May 17, 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
    NM, US
    Reporter Occupation
    OTHER

    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. PART 314.467, LOT 7761351: RELEASE TO WAREHOUSE DATE: DECEMBER 01, 2014. MANUFACTURED BY SYNTHES MONUMENT. NO NON-CONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) 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 COMPLETED: THE STARDRIVE SCREWDRIVER WAS OBSERVED WITH STRIPPED/DEFORMED AT THE TIP. ADDITIONALLY, WEAR AND TEAR ALONG THE SHAFT WAS OBSERVED. BASED ON THE VISUAL INSPECTION, THE RECEIVED CONDITION AGREED WITH THE COMPLAINT DESCRIPTION, THEREFORE THE COMPLAINT IS CONFIRMED. THE REPORTED CONDITION OF THE SCREWDRIVER WILL NOT FIT INSIDE SCREW HEAD WAS UNABLE TO BE REPLICATED AS THE SCREW HEADS ARE NOT RETURNED FOR A FUNCTIONAL TEST. DIMENSIONAL ANALYSIS OF THE DEVICE COULD NOT BE OBTAINED DUE TO RECEIVED CONDITION OF POST MANUFACTURING DAMAGE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED DURING THE INVESTIGATION. 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. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING USAGE COULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION. THEREFORE, THE COMPLAINT IS CONFIRMED FOR STRIPPED/DEFORMED TIP, HOWEVER IT IS UNCONFIRMED FOR NOT FITTING WITH SCREW HEAD AS THE SCREW WAS NOT RETURNED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    NO PATIENT INVOLVEMENT REPORTED. DATE OF EVENT IS UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: KWQ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ON (B)(6) 2018, WHILE INSPECTING THE BOX AND IT¿S CONTENT, SALES CONSULTANT NOTED THAT THE TIP OF THE STARDRIVE SCREWDRIVER SHAFT NOTED TO HAVE A SMALL BURR AND WOULD NOT FIT INSIDE THE SCREW HEADS. THERE WERE NO PATIENT AND PROCEDURE 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
    449765 STARDRIVE SCREWDRIVER SHAFT T8 105MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7761351 10886982188922

    Patients

    Seq Age Sex Outcome Treatment
    1