BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 3083211 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10547
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE THIS ISSUE WAS ADDRESSED ON SEVERAL PRIOR COMPLAINTS AND AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. AS PART OF THE CORRECTIVE ACTION, THE MATERIAL WAS CHANGED FROM 440A STAINLESS STEEL TO 465PH STAINLESS STEEL (B)(4) AND WAS IMPLEMENTED ON SHAFT(B)(4) LOT NUMBERS 4487955 AND 4480644. THE SHAFT ON THIS COMPLAINT IS L/N 4343011 AND WAS PRODUCED PRIOR TO THE IMPLEMENTED CORRECTIVE ACTION. THE ISSUE WAS DEEMED VALID AND WAS ADDRESSED. THE SHAFT ON THIS DEVICE WAS PRODUCED PRIOR TO IMPLEMENTATION OF THE CAPA CORRECTIVE ACTION. THEREFORE, THIS COMPLAINT IS VALID AS DISPOSITIONED ON PRIOR COMPLAINTS BUT CORRECTIVE ACTION TO ADDRESS IT HAS ALREADY BEEN IMPLEMENTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION OF A SUB-TALAR FUSION PROCEDURE, THE SURGEON BROKE THE TIP OF THE SCREWDRIVER INTO THE WOUND. THE BROKEN PIECE WAS RETRIEVED FROM THE WOUND. THE SURGEON SELECTED ANOTHER SCREWDRIVER TO COMPLETE THE PROCEDURE WITH NO FURTHER INCIDENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185706 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE 4360367

    Patients

    Seq Age Sex Outcome Treatment
    1