BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP UNI FB KEEL OSTEOTOME

    MDR report key: 6415999 · Received March 18, 2017

    Report

    Report Number
    1818910-2017-14889
    Event Type
    Malfunction
    Date Received
    March 18, 2017
    Date of Event
    February 27, 2017
    Report Date
    February 27, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (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

    EXAMINATION OF THE SUBMITTED OSTEOTOME CONFIRMED THE 202446916 END CAP COMPONENT HAS FRACTURED AT THE CENTER OF THE PIN THAT SECURES THE CAP TO THE SHAFT. THE ROOT CAUSE IS BEING ATTRIBUTED TO SUSPECTED MISUSE. THE SIGMA UNICONDYLAR SURGICAL TECHNIQUE (.25M0908 / 0612-05-507) STATES "USE THE TIBIAL OSTEOTOME TO GENTLY REMOVE THE BONE FROM THE KEEL SLOT. DO NOT IMPACT FORCEFULLY AS THIS CAN CAUSE A BREAK OF THE POSTERIOR TIBIA". NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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.

    Description of Event or Problem · 1

    THE INSTRUMENT CAME APART IN THE WASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197985 SIGMA HP UNI FB KEEL OSTEOTOME KNEE INSTRUMENT/TRIAL HWM DEPUY ORTHOPAEDICS, INC. GM0909

    Patients

    Seq Age Sex Outcome Treatment
    1