BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP FBT KEEL PUNCH IMPACT

    MDR report key: 7873035 · Received September 13, 2018

    Report

    Report Number
    1818910-2018-69321
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 20, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    HWA
    UDI-DI
    10603295227717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED IN THEATRE 11 AT LGH WITH DR (B)(6) AS THE SURGEON. HE WAS IMPACTING THE KEEL PUNCH INTO THE TIBIA, WHEN THE KEEL PUNCH IMPACTOR CAME APART. THE BUTTON WHICH YOU PRESS TO ATTACH THE KEEL PUNCH APPEARS TO HAVE SHEARED OFF INSIDE. THEY FOUND ALL THE PIECES AT THE TIME AND X RAYS OF THE PATIENT CONFIRM THAT NOTHING WAS LEFT IN THE PATIENT. THEY ARE HAPPY THAT THE PATIENT CAME TO NO HARM. THIS CAUSED AROUND 15 MINUTES DELAY IN THE PROCEDURE WHILE THEY CONFIRMED THIS AND OPENED ANOTHER TRAY. INSTRUMENT CONCERNED IS KEEL PUNCH IMPACTOR 950502055. LOT NO NB12633.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716242 SIGMA HP FBT KEEL PUNCH IMPACT KNEE INSTRUMENT : HANDLES HWA DEPUY ORTHOPAEDICS INC 1818910 NB12633 10603295227717

    Patients

    Seq Age Sex Outcome Treatment
    1