BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    MDR report key: 3080822 · Received April 26, 2013

    Report

    Report Number
    8030965-2013-11126
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    August 23, 2012
    Report Date
    August 23, 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. PLACEHOLDER.

    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. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MANUFACTURING EVALUATION REPORTS THAT THE COMPLAINT DEVICE WAS RECEIVED WITH THE HOLDING FORK WITH PINS ON THE TIP INTACT AND THE MOVABLE CARDAN LINK STILL IN PLACE. THE REST OF THE CARDON JOINT INCLUDING THE T8 STARDRIVE HEAD WERE BROKEN OFF AND MISSING. DUE TO THE DAMAGE, THE AFFECTED DIMENSIONS FOR THIS DEVICE COULD NOT BE CHECKED. THE INSTRUMENT MET THE SPECIFICATIONS IN PLACE AT THE TIME OF MANUFACTURING AND DISTRIBUTION. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALS THAT THE ANGLED SCREWDRIVER WAS DESIGNED TO ALLOW A ZERO-P SCREW TO BE INSERTED WHERE THE ANATOMY OF THE PATIENT LIMITS THE ACCESS FOR SCREW INSERTION. THIS IS ACCOMPLISHED VIA A CARDON (UNIVERSAL) JOINT WITH A SLEEVE THAT DIRECTS THE SCREWDRIVER TIP AT A PRESET ANGLE OF 40 DEGREES, WHICH MATCHES THE ANGLE OF THE SCREWS IN THE PLATE. THE TIP OF THE DRIVER ASSEMBLY IS TESTED TO WITHSTAND A MAXIMUM TORQUE OF 2.0NM, WHICH IS GREATER THAN THE 1.2NM TORQUE REQUIRED TO LOCK THE SCREW TO THE PLATE. THE EVIDENCE INDICATES THAT THE POSSIBLE ROOT CAUSE COULD HAVE BEEN DUE TO EXCESSIVE TORQUE (GREATER THAN 2.0NM), WHICH WOULD HAVE DAMAGED THE CARDON JOINT AND (OR) BROKEN THE TIP. IT SHOULD ALSO BE NOTED THAT THE OPERATOR USED A CUSTOM SRT WELDED COUNTERTORQUE HANDLE AND OUTER SLEEVES IN CONJUNCTION WITH THE STANDARD INNER SHAFT. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE IF THEIR USE COULD HAVE CAUSED FAILURE OF THE INNER SHAFT. UPON FOLLOW UP, USAGE OF THE CUSTOM SRT OUTER SLEEVES WAS CONFIRMED, AND THIS REDUCES THE POSSIBILITY THAT THE STANDARD OUTER SLEEVES AND COUNTERTORQUE HANDLES RETURNED WITH THE COMPLAINT DEVICES WERE CONTRIBUTING FACTORS TO THE FAILURE OF THE INNER SHAFT.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL DECOMPRESSION FUSION (ZERO-P) PROCEDURE, BOTH DRIVERS BROKE AT THE U-JOINT AS THE SURGEON WAS INSERTING SCREWS. ALL FRAGMENTS WERE RETRIEVED AND ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT REPORTED. THIS REPORT IS 2 OF 2 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182994 ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING OVE SYNTHES GMBH 7938884

    Patients

    Seq Age Sex Outcome Treatment
    1