BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR EXTRACTION SCREWDRIVER

    MDR report key: 3040259 · Received April 8, 2013

    Report

    Report Number
    1719045-2013-10558
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 30, 2012
    Report Date
    April 30, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING VISUAL EVALUATION NOTED THE PART EXHIBITED SOME MINOR SCUFF MARKS ON THE SHAFT. THE KNURLED KNOB AND THE EXTERNAL THREAD EXHIBITS SIGNS OF DISCOLORATION. THE EVALUATION INDICATES THE REPORTED FAILURE IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESSES AT TELEFLEX MEDICAL. BASED ON THE EVALUATION AND THE UNKNOWN ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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)(6) 2012.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ACF C5-C6, C6-C7 PROCEDURE, THE SURGEON WAS REMOVING ONE OF THE SCREWS TO REPOSITION IT. THE THREADS ON THE INNER SHAFT OF THE DRIVER BROKE OFF INTO THE SCREW HEAD. THE SCREW WAS REMOVED WITH THE TIP OF THE INNER SHAFT REMAINING IN THE HEAD OF THE SCREW. THERE WERE NO FRAGMENTS TO RETRIEVE. THE SURGEON INSERTED ANOTHER SCREW WITH A DIFFERENT DRIVER AND COMPLETED THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143536 INNER SHAFT FOR EXTRACTION SCREWDRIVER HXX SYNTHES MONUMENT 6529477

    Patients

    Seq Age Sex Outcome Treatment
    1