BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER T25/SELF-RETAINING

    MDR report key: 7451453 · Received April 23, 2018

    Report

    Report Number
    2939274-2018-51865
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    January 1, 2018
    Report Date
    April 3, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982067791
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS IS A PRODUCT PROBLEM. PART # 03.010.107; SYNTHES LOT # 5781515; SUPPLIER LOT # NA; RELEASE TO WAREHOUSE DATE: MAY 13, 2008; MANUFACTURED BY SYNTHES BRANDYWINE; NO NONCONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. 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. IT WAS REPORTED THAT THE STARDRIVE SCREWDRIVER T25/SELF-RETAINING (03.010.107 LOT 5781515) WAS ¿MANGLED¿ AND WAS UNABLE TO MATE WITH A DRIVE RECESS. THE STARDRIVE SCREWDRIVER T25/SELF-RETAINING (03.010.107) IS NOTED IN FOUR SYSTEM TECHNIQUE GUIDES: ANGULAR STABLE LOCKING, SUPRAPATELLAR INSTRUMENTATION FOR TITANIUM CANNULATED TIBIAL NAIL, TITANIUM CANNULATED HUMERAL NAIL, AND TITANIUM CANNULATED ADOLESCENT LATERAL ENTRY FEMORAL NAIL. IN EACH INSTANCE, THE DRIVER CAN BE UTILIZED FOR SCREW/ENDCAP INSERTION/REMOVAL SO LONG AS THE SCREW HAS A T25 DRIVE RECESS. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL DRIVE TIP WAS FOUND TO BE STRIPPED BUT INTACT. WHETHER THE COMPLAINT CONDITION IS ABLE TO BE REPLICATED IS NOT APPLICABLE DUE TO POST-MANUFACTURING DAMAGE. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER, BASED ON DEVICE AGE (MFG 2008), THE FAILURE IS CONSISTENT WITH WEAR AND TEAR OF A MULTIUSE DEVICE OVER 10 YEARS OF USE. RELEVANT DRAWINGS FOR THE RETURNED DEVICE WERE REVIEWED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. NO DIMENSIONAL ANALYSIS IS POSSIBLE DUE TO POST-MANUFACTURING DAMAGE. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL AND HARDNESS REVIEWS, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MANUFACTURING RECORD REPORTS (MRRS), NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW NOT AVAILABLE TO REPORT AT THIS TIME. 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 THE HEAD OF A STARDRIVE SCREWDRIVER T25 WAS MANGLED AND NOTHING COULD GO IN THE STAR PATTERNED HEAD OF THE SCREWDRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295204 STARDRIVE SCREWDRIVER T25/SELF-RETAINING SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5781515 10886982067791

    Patients

    Seq Age Sex Outcome Treatment
    1