BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS

    MDR report key: 3003782 · Received March 14, 2013

    Report

    Report Number
    8030965-2013-10496
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    December 7, 2011
    Report Date
    December 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. ORIGINAL AWARENESS DATE IS (B)(4) 2011.

    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 RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND ONE OF THE FOUR FLANGES OF THE CRUCIFORM DRIVE WAS COMPLETELY BROKEN OFF AND MISSING FROM THE DRIVER. THE REMAINING THREE FLANGES WERE BENT IN THE DIRECTION EXPECTED FROM A CLOCKWISE TORSIONAL LOAD. DUE TO DAMAGE, THE DIMENSIONS COULD NOT BE CHECKED. THE COMPLAINT WAS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. A DESIGN EVALUATION WAS PERFORMED AS PART OF THE PRODUCT DEVELOPMENT ANALYSIS. THE MOST LIKELY CAUSE OF THE FAILURE IS OFF-AXIS LOADING. IF THE DRIVER COULD NOT GET FULLY SEATED AT THE TIME OF FINAL TIGHTENING, THE FLANGES COULD BE LOADED ASYMMETRICALLY AND HAVE SEEN HIGHER STRESSES THAN TYPICALLY EXPECTED. THE DRIVER IS DESIGNED IN SUCH A WAY THAT THE SCREW RECESS SHOULD STRIP BEFORE SEEING ANY DRIVER BREAKAGE. IT CANNOT BE DETERMINED IF THE DEVICE WAS BEING USED OFF-AXIS, OR IF THERE ARE ANY OTHER CIRCUMSTANCES AT THE TIME OF IMPLANTATION THAT COULD HAVE LED TO THIS MALFUNCTION. THEREFORE, THE COMPLAINT IS INDETERMINATE FROM A DESIGN STANDPOINT.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION, AS THE SURGEON WAS TIGHTENING THE FINAL SCREW, ONE OF THE PRONGS ON THE SCREWDRIVER BROKE. THE BROKEN FRAGMENTS WERE RETRIEVED WITH NO ADVERSE EVENT TO PATIENT. THE SURGEON WAS ABLE TO USE ANOTHER SCREWDRIVER FROM THE SET TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107525 LOCKING DRIVER FOR CSLP QUICK LOCK SCREWS HXX SYNTHES GMBH 1631246

    Patients

    Seq Age Sex Outcome Treatment
    1