BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 STARDRIVE SHAFT F/MATRIX CANNULATED/LONG

    MDR report key: 3070628 · Received April 22, 2013

    Report

    Report Number
    1719045-2013-10742
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. BASED ON THE DEVICE HISTORY REVIEW, THIS COMPLAINT IS INVALID FROM A MANUFACTURING PERSPECTIVE. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT AN EXTREMELY SMALL PART OF THE CORNER OF ONE OF THE STARDRIVE POINTS IS WORN OR BROKEN OFF. TWO OTHER TIPS HAVE VERY SLIGHT DEFORMATION ON THE EDGES. THERE ARE MARKS ON THE FINAL APPROXIMATELY 2 TO 2.5 MM OF THE TIP SHOWING THAT IT HAS BEEN ENGAGED INTO A SCREW RECESS. EVALUATION OF THE DESIGN INDICATES THAT IT IS ACCEPTABLE FOR THE INTENDED USE AND EXAMINATION OF THE PART SHOWS THAT IT HAS BEEN USED WITHOUT THE TORQUE LIMITING HANDLE AS REQUIRED. THEREFORE THE COMPLAINT IS INVALID.

    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)

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.LOT NUMBER WAS ORIGINALLY REPORTED AS 6543880, CORRECT LOT NUMBER FOR THIS DEVICE IS 6547230.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN MIS PROCEDURE THAT ONE OF THE POINTS ON THE DRIVER TIP BROKE OFF INTO THE SCREW. THE FRAGMENT WAS RETRIEVED FROM SCREW AND A BACK UP DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171342 T25 STARDRIVE SHAFT F/MATRIX CANNULATED/LONG HXX SYNTHES MONUMENT 6457230

    Patients

    Seq Age Sex Outcome Treatment
    1