BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    MDR report key: 3083442 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11131
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 5, 2012
    Report Date
    July 5, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE DRIVER WAS RECEIVED WITH A FRACTURED UNIVERSAL JOINT AND SOME SCRATCHES ON THE DISTAL SURFACE. THE TECHNIQUE GUIDE FOR THE ZERO-P INSTRUMENTS AND IMPLANTS RECOMMENDS TO TIGHTEN THE SCREW TO THE PLATE WITH 1.2 NM USING A TORQUE LIMITING ATTACHMENT. THE TECHNIQUE GUIDE ALSO INSTRUCTS THE SURGEON TO USE THE ANGLED INSTRUMENTS IF THE PATIENT ANATOMY DOES NOT ALLOW USE OF STRAIGHT INSTRUMENTS. THE FAILURES OF THE DISTAL TIP ARE DUE TO STRESSES THAT EXCEED THE MATERIAL OR WELD STRENGTH. SINCE THE FORCE DELIVERED BY THIS INSTRUMENT IS NOT TORQUE LIMITING, THE AMOUNT OF TIGHTENING TORQUE IS UNKNOWN. ACCORDING TO THE RISK ASSESSMENT, TORQUES ABOVE AND BELOW THE RECOMMENDED 1.2 NM PRESENT CLINICAL RISKS ASSOCIATED WITH THE SUCCESS OF THE PROCEDURE. IN ADDITION, DELIVERING A TORQUE BEYOND THE STRENGTH OF THE INSTRUMENT CAN LEAD TO BREAKAGE OF THE DEVICE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. AN INTERNAL CORRECTIVE ACTION IS NOT REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGLED SCREWDRIVER THAT BROKE AS THE SURGEON WAS PLACING THE SCREW TO LOCK INTO THE PLATE. ALL PIECES WERE RETRIEVED, SURGERY COMPLETED AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR THREE ANGLED SCREWDRIVERS THAT BROKE. IT SHOULD BE NOTED THAT ONLY ONE SCREWDRIVER WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184458 ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING OVE SYNTHES GMBH 8087193

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR