BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX PRO-OVAL STRAIGHT PUNCH

    MDR report key: 3721625 · Received April 2, 2014

    Report

    Report Number
    1219602-2014-00093
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 24, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE ACUFEX PRO OVAL STRAIGHT PUNCH WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE COMPLAINT OF THE JAW BREAKING OFF. FURTHER EXAMINATION OF THE DEVICE CONFIRMED THE CUTTING EDGE HAS BEEN FILED FLAT. THIS CONDITION WOULD REQUIRE EXCESSIVE FORCE BE APPLIED TO CUT. THE HANDLE HAS BEEN ETCHED WITH ¿(B)(4)¿ HANDLE HAS BEEN BEAD BLASTED AND LASER MARKING TAPED OVER. DEVICE APPEARS TO HAVE BEEN REPAIRED BY A UNAUTHORIZED THIRD PARTY RESULTING IN THE DEVICES FAILURE. THE REPAIR IS INCONSISTENT WITH CURRENT SMITH & NEPHEW PRACTICES. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    DURING A KNEE ARTHROSCOPY UTILIZING THE ACUFEX PRO-OVAL STRAIGHT PUNCH, IT WAS REPORTED THAT THE JAW END OF THE PUNCH BROKE IN THE PATIENT¿S KNEE. THE METALLIC PIECE WAS REMOVED BY AN INCISION MADE OVER IT. A BACK-UP DEVICE WAS AVAILABLE. IT WAS REPORTED THAT THE INCIDENT DID NOT RESULT IN ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199189 ACUFEX PRO-OVAL STRAIGHT PUNCH ACUFEX PRO-OVAL STRAIGHT PUNCH NBH MANSFIELD MANUFACTURING SITE 7207181 50212062

    Patients

    Seq Age Sex Outcome Treatment
    1