BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LOCKING DRILL GUIDE

    MDR report key: 3063741 · Received April 17, 2013

    Report

    Report Number
    2530088-2013-10443
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    October 18, 2011
    Report Date
    October 18, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE INSTRUMENT APPEARS TO BE TO THE CORRECT SPECIFICATION WITH REGARD TO A DESIGN STANDPOINT. ONE OF THE FLANGES HAS BROKEN OFF AT THE SHOULDER. THERE COULD BE SEVERAL FACTORS CONTRIBUTING TO THE INCIDENT. THIS DEVICE WAS MADE APPROXIMATELY 9 YEARS AGO, AND OVER THE YEARS THROUGH ACCUMULATED STRESS AND FATIGUE, THAT CAUSE IT TO BRAKE. ALSO, IF EXCESSIVE SIDE LOAD IS IMPARTED ON THE DEVICE, A CANTILEVER FORCE COULD CAUSE A BREAKAGE. THIS COULD HAPPEN IF THE INSTRUMENT IS BEING USED TO MANIPULATE THE PLATE INSIDE THE WOUND. THROUGH THIS DEVICES LIFETIME, IT CANNOT BE CONCLUDED WHEN IF ANY EXCESSIVE CANTILEVER FORCES WERE SEEN. IF THAT WAS THE CASE, IT IS POSSIBLE THE INSTRUMENT COULD BE HAVE FATIGUED DURING NORMAL USE AT SOME POINT LATER. THIS COMPLAINT IS THEREFORE FOUND TO BE INDETERMINATE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACS PROCEDURE, LEVELS C5-6, C6-7, A SINGLE LOCKING DRILL GUIDE MALFUNCTIONED. THE SURGEON PLACED THE PLATE AND STARTED DRILLING AND INSERTING THE SCREWS. SURGEON DRILLED A HOLE USING THE SINGLE LOCKING DRILL GUIDE INSERTED A SCREW AND WENT TO THE NEXT HOLE IN THE PLATE WHEN THE SURGEON NOTED THE TIP OF THE DRILL GUIDE WAS MISSING. SURGEON WENT TO THE PREVIOUS SCREW HE INSERTED, REMOVED THE SCREW AND FOUND THE TIP OF THE DRILL GUIDE. SURGEON DID REMOVE THE BROKEN TIP AND RE-INSERTED THE SAME SCREW. THE SCREWS WERE NOT TIGHTENED DOWN. SURGEON COMPLETED THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164646 SINGLE LOCKING DRILL GUIDE FZX SYNTHES BRANDYWINE 4327827

    Patients

    Seq Age Sex Outcome Treatment
    1