BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8SELF-RETAINING/QC

    MDR report key: 3050885 · Received April 10, 2013

    Report

    Report Number
    8030965-2013-01575
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION RECEIVED FROM SALES CONSULTANT. THE RETURNED DRIVER SHAFT SHOWS EVIDENCE OF FRACTURE DURING TIGHTENING. ALL SIX LOBES DISPLAY DEFORMATION IN A DIRECTION CONSISTENT WITH APPLYING TORQUE TO TIGHTEN A SCREW. THE DRIVER SHAFT IS MISSING ABOUT 1MM OF THE DISTAL TIP. THE LIBERATED PART IS NOT INCLUDED WITH THE RETURN. THE ZERO-P SYSTEM INCLUDES THE T8 SCREWDRIVER SHAFT. IN CONJUNCTION WITH QUICK COUPLING HANDLE, (B)(4), AND 1.2 NM TORQUE LIMITING ADAPTER, (B)(4), AND THE SURGEON USES THIS SHAFT TO INSERT AND TIGHTEN SCREWS. THE CHU ENGINEER REVIEWED DRAWING (B)(4) REVISION. (B)(4). THIS MATERIAL HAS NOT CHANGED SINCE THE RELEASE OF THE INSTRUMENT. THIS DEVICE FAILED DUE TO SHEAR STRESSES ABOVE THE ULTIMATE MATERIAL SHEAR STRENGTH. THE CALCULATIONS SHOW THAT IF THE DRIVER IS FULLY SEATED, THE STRESS INDUCED BY(B)(4) APPROACHES THE YIELD STRENGTH. THE STRESSES INCREASE IF THE DRIVER TIP IS NOT FULLY SEATED IN THE SCREW. THIS COULD LEAD TO AN ULTIMATE FAILURE. THE DESIGN RISK ASSESSMENT WAS RE-REVIEWED BY PRODUCT DEVELOPMENT AND IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS USED WITH THE ZERO P SYSTEM.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE WHEN PERFORMING AN ANTERIOR CERVICAL DISECTOMY INFUSION, THE SCREW DRIVER TIP BROKE OFF WHEN THE FINAL SCREW WAS INSERTED. THE SURGEON USED A HIGH-SPEED BURR TO REMOVE THE SCREWDRIVER TIP FROM THE SCREW HEAD. THE EVENT RESULTED IN SURGERY BEING EXTENDED BY APPROXIMATELY ONE HOUR. IT WAS REPORTED THERE WAS NO ADVERSE EVENT TO PATIENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153903 STARDRIVE SCREWDRIVER SHAFT T8SELF-RETAINING/QC OVE SYNTHES GMBH 8142410

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention