BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC

    MDR report key: 5641087 · Received May 9, 2016

    Report

    Report Number
    1719045-2016-10381
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE PRODUCT CODE IS LXH. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 INVESTIGATION SUMMARY: ONE (1) STARDRIVE SCREWDRIVER SHAFT (PART: 03.614.019 / LOT: 6070267) WAS RECEIVED FOR EVALUATION. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DRIVER TIP WAS FOUND TO BE ROUNDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER, THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF TORQUE WHEN THE DRIVER IS NOT FULLY ENGAGED IN THE SCREW RECESS. A DEVICE HISTORY RECORD REVIEW AND DRAWING REVIEW WERE DONE AS A PART OF THIS INVESTIGATION. THE DEVICE IS UTILIZED IN THE SYNAPSE OCT SYSTEM FOR POSTERIOR STABILIZATION OF THE UPPER SPINE. THE DRIVER IS SPECIFICALLY UTILIZED TO INSERT/FINAL TIGHTEN LOCKING SCREWS. THE SYSTEM TECHNIQUE GUIDE STATES THAT, AFTER FINAL ADJUSTMENT OF THE CONSTRUCT, THE USER SHOULD FULLY TIGHTEN ALL LOCKING SCREWS WITH THE SCREWDRIVER SHAFT AND A 2 NM TORQUE LIMITING HANDLE. THE CONSTRUCT SHOULD BE RIGIDLY LOCKED. FINAL TIGHTENING SHOULD BE ACCOMPLISHED AFTER ALL LOCKING SCREWS HAVE BEEN PLACED, AND SHOULD BE AIDED BY THE COUNTERTORQUE TOOL. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED: TOP-LEVEL. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER WITH NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES IDENTIFIED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; HOWEVER, THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF TORQUE WHEN THE DRIVER IS NOT FULLY ENGAGED IN THE SCREW RECESS. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE 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

    (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT DURING AN INITIAL POSTERIOR CERVICAL FUSION AT LEVELS C4-C5 AND C5-C6 ON (B)(6) 2016, THE SCREWDRIVER TIP SLIPPED OUT OF THE SCREW HEAD RECESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY OR HARM TO THE PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295390 STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC SCREWDRIVERS HXX SYNTHES MONUMENT 6070267

    Patients

    Seq Age Sex Outcome Treatment
    1