BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM THREADED GUIDE WIRE 150MM

    MDR report key: 3081148 · Received April 26, 2013

    Report

    Report Number
    3003506883-2013-10145
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    July 19, 2012
    Report Date
    July 19, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K962823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. MANUFACTURING EVALUATION REPORTS THAT THE GUIDE WIRE WAS RECEIVED AS THREE PIECES IN A PLASTIC BAG. MARKS WERE VISIBLE THROUGH OUT THE LENGTH OF THE PART. THE BREAK POINTS ON EACH OF THE THREE PIECES WERE NOTICED TO BE UNUSUALLY PERFECT AND FLAT BREAKS. ONLY THE RAW MATERIAL AND THE OVERALL DIAMETER COULD BE CHECKED ON THIS PART. SINCE THE PART WAS DAMAGED, THE OVERALL LENGTH COULD NOT BE CHECKED. BECAUSE NO LOT NUMBER WAS AVAILABLE OR PROVIDED, MANUFACTURING RECORDS COULD NOT BE CHECKED AND WITH THE PART BEING DAMAGED, THIS COMPLAINT WAS FOUND TO BE INDETERMINATE. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANKLE FRACTURE PROCEDURE, THE GUIDE WIRE BROKE OFF. THE SURGEON TIGHTENED THE CHUCK AND A SECOND PIECE BROKE OFF, ALL PIECES WERE REMOVED AND THE CASE WAS COMPLETED WITHOUT HARM TO THE PATIENT. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182060 1.25MM THREADED GUIDE WIRE 150MM HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1