BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM NON-THREADED GUIDE WIRE150MM

    MDR report key: 3021451 · Received March 26, 2013

    Report

    Report Number
    2520274-2013-10979
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    November 10, 2011
    Report Date
    November 10, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. ADDITIONAL PRODUCT CODES: HTY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THIS DEVICE WAS RECEIVED AS TWO BROKEN PIECES, MEASURING APPROXIMATELY 117.00MM AND 33.00MM IN LENGTH. MULTIPLE INDENTATIONS CAN BE SEEN ON THE 33.00MM SECTION OF THE GUIDE WIRE. THE DAMAGE AT THE BREAK-POINT APPEARS TO HAVE BEEN CAUSED BY THE JAWS OF THE GUIDE WIRE EXTRACTION DEVICE.

    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. ADDITIONAL NARRATIVE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 1ST METATARSAL FUSION, SURGEON INSERTED A 1.25MM GUIDE WIRE AND STARTED TO DRILL. THE DRILL BIT SNAPPED THE WIRE. NO PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY HARM TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123347 1.25MM NON-THREADED GUIDE WIRE150MM LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1