BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED STERILE PIN 200 MM

    MDR report key: 4945040 · Received July 24, 2015

    Report

    Report Number
    3000931034-2015-00128
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 7, 2015
    Manufacturer
    TORNIER S.A.S.
    Product Code
    JDW
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY RECORD WAS REVIEWED. RESULTS: DEVICE WAS MADE TO SPECIFICATION. BREAKAGE MAY BE RELATED TO OVER-TIGHTENING OF THE DEVICE DURING USE. CONCLUSIONS: ROOT CAUSE OF DEVICE BREAKAGE COULD NOT BE CONFIRMED. THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. THE INFORMATION CONTAINED IN THIS REPORT IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS REGARDING MEDICAL DEVICE REPORTING AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY OR MAY NOT BE FACTUALLY CORRECT.

    Description of Event or Problem · 1

    DURING SURGERY THE GUIDE PIN HIT RESISTANCE THROUGH HARD BONE. DURING REMOVAL OF A REAMER, THE GUIDE PIN BROKE. SURGEON TRIED TO RETRIEVE THE PIECE BUT COULD NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481799 AEQUALIS REVERSED STERILE PIN 200 MM NONE JDW TORNIER S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other