BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG

    MDR report key: 10740614 · Received October 27, 2020

    Report

    Report Number
    2939274-2020-04829
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Report Date
    September 30, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982070944
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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, H4, H6: PART 03.100.045, LOT 5130784: RELEASE TO WAREHOUSE DATE: APRIL 06, 2006. MANUFACTURED BY SYNTHES MONUMENT. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. 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. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, THE SCREWDRIVER SHAFT HAD A NICK AT THE PROXIMAL END OF THE DEVICE AND ALSO SCRATCHES AND SCUFFS CONSISTENT WITH FIELD USAGE WERE OBSERVED ON THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. A FUNCTIONAL TEST CANNOT BE PERFORMED AS THE DEVICE WAS RETURNED BY ITSELF. THE DIAMETER OF THE SHAFT WAS MEASURED; IT MEASURED WITHIN THE SPECIFIED DIMENSIONS. THE RELEVANT DOCUMENTS WERE REVIEWED; NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THE COMPLAINT CONDITION CANNOT BE CONFIRMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 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

    REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 AN UNKNOWN DATE, THE 4 STARDRIVE SCREWDRIVER SHAFTS WERE DAMAGED. THE STARDRIVE SHAFTS WOULD NOT LOAD INTO A STANDARD AO QUICK CONNECT CHUCK ON THE DRILL, SEVERAL CHUCKS AND VARIATIONS WERE TRIED. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN AO QUICK CONNECT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR 1 STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205633 STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.100.045 5130784 10886982070944

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN AO QUICK CONNECT| UNKNOWN AO QUICK CONNECT