BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.25MM GUIDE WIRE 200MM

    MDR report key: 3052301 · Received April 11, 2013

    Report

    Report Number
    3003506883-2013-10100
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    ACCORDING TO THE REPORTER, DURING A PROCEDURE AT C2-ODONTOID-DENS, THE K-WIRE BROKE IN THE PATIENTS BONE. THE SURGEON REPORTEDLY SAID THE K-WIRE BROKE DURING DRILLING, AND PIECES OF IT CAME OUT THE AIMING ARM. THE SURGEON COMPLETED THE PROCEDURE AND REPORTED THAT ALL PIECES WERE RETRIEVED. HOWEVER, THE NURSE AND THE SCRUB TECH WERE UNSURE IF ALL PIECES WERE RETRIEVED. NO X-RAYS WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155963 1.25MM GUIDE WIRE 200MM HWT SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR