BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC

    MDR report key: 6168668 · Received December 12, 2016

    Report

    Report Number
    1719045-2016-10906
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Report Date
    November 21, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    10705034717432
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICES. THE RETURNED DRIVERS WERE EXAMINED AND BOTH DRIVE TIPS WERE FOUND TO BE BROKEN, WITH FRAGMENTS MISSING FROM MULTIPLE LOBES ON EACH DRIVER. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF TORQUE WHEN THE DRIVER TIP IS NOT FULLY ENGAGED WITH THE SCREW¿S DRIVE RECESS AND/OR THE APPLICATION OF EXCESSIVE FORCE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE STARDRIVE SCREWDRIVER SHAFT T25/6MM HEX COUPLING (03.620.003) AND STARDRIVE SCREWDRIVER SHAFT T25/6MM HEX ¿ LONG (03.620.002) ARE NOTED IN MULTIPLE SYSTEM TECHNIQUE GUIDES INCLUDING: PANGEA DEGENERATIVE, CANNULATED PANGEA, AND ANTEGRA. IN EACH SYSTEM THE DRIVER SHAFTS ARE AVAILABLE FOR SCREW INSERTION AND REMOVAL. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENTS WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL AND TIP PROFILE. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. 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

    ADDITIONAL NARRATIVE: DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.620.003, LOT# 5061677. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: DEC 08, 2015. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 IN THE STERILE PROCESSING ROOM, ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC AND ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC-LONG DEVICES WERE BOTH DISCOVERED TO BE BENT UP AND TWISTED DUE TO OVERUSE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819230 STARDRIVE SCREWDRIVER SHAFT T25/6MM HXC SCREWDRIVERS HXX SYNTHES MONUMENT 5061677 10705034717432

    Patients

    Seq Age Sex Outcome Treatment
    1