BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 9678631 · Received February 6, 2020

    Report

    Report Number
    2939274-2020-00697
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 14, 2020
    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
    WA, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H4, H6 INVESTIGATION SUMMARY VISUAL INSPECTION: THE T-HANDLE WITH QUICK COUPLING (PART # 311.44 / LOT # 9925586) WAS RECEIVED ATTACHED TO A STARDRIVE SCREWDRIVER SHAFT T8 105MM (PART # 314.467 / LOT # 7525379). THE DISTAL TIP OF THE SCREW DRIVER SHAFT WAS TWISTED IN THE DIRECTION OF TIGHTENING. IT WAS UNABLE TO DETERMINE IF THERE WAS DAMAGE TO THE COUPLING AS THE DEVICE COULD NOT BE REMOVED FROM THE T-HANDLE WITH QUICK COUPLING. FUNCTIONAL TEST: FUNCTIONAL TESTING SHOWED THAT THE SLEEVE OF THE T-HANDLE WITH QUICK COUPLING CAN TOGGLE HOWEVER IT DOES NOT RELEASE THE ATTACHED SCREWDRIVER. ALTHOUGH THE SLEEVE MOVES SMOOTHLY, THE SCREWDRIVER REMAINS IN PLACE THUS THE REPORTED CONDITION OF UNABLE TO DISASSEMBLE WAS CONFIRMED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? YES; DEVICES CANNOT BE DISASSEMBLED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO JAMMED CONDITION OF THE DEVICES. RELEVANT FEATURES WERE NOT ACCESSIBLE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS). CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED STARDRIVE SCREWDRIVER SHAFT T8 105MM AS IT CANNOT DISASSEMBLE FROM THE RECEIVED T-HANDLE WITH QUICK COUPLING. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED ITS POSSIBLE THE DEVICES EXPERIENCED UNINTENDED FORCES LEADING TO AN INTERNAL MECHANICAL FAILURE. THE COMPONENTS OF THE DEVICES MAY HAVE GALLED TOGETHER. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY: PART # 314.467; LOT # 7525379; MANUFACTURED DATE: 11-MARCH-2014. A MANUFACTURING RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE (B)(4) NO MANUFACTURING RECORD EVALUATION IS REQUIRED. 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

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRO-CODE: KWQ. DEVICE RECEIVED. REPORTER IS SYNTHES REP. 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. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED. 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) 2020, THE T HANDLE WITH QUICK COUPLING AND A STARDRIVE SCREWDRIVER SHAFT WERE STUCK TOGETHER. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 105 MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139386 STARDRIVE SCREWDRIVER SHAFT T8 105MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.467 7525379 10886982188922

    Patients

    Seq Age Sex Outcome Treatment
    1