BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP UNI FB KEEL OSTEOTOME

    MDR report key: 6159452 · Received December 9, 2016

    Report

    Report Number
    1818910-2016-32972
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    December 6, 2016
    Report Date
    December 6, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    HWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE CONFIRMED THE END CAP COMPONENT HAS FRACTURED AT THE CENTER OF THE PIN THAT SECURES THE CAP TO THE SHAFT. PREVIOUS INVESTIGATIONS HAVE BEEN CONDUCTED FOR END CAP COMPONENTS BEING DISASSOCIATED FROM THE HANDLE. THE PREVIOUS INVESTIGATIONS FOUND NO EVIDENCE INDICATING MATERIAL OR MANUFACTURING WERE CONTRIBUTING FACTORS AND DETERMINED THE FAILURE COULD BE RECREATED BY HAMMERING THE END CAP. 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". THE ROOT CAUSE WAS ATTRIBUTED TO SUSPECTED MISUSE. HOWEVER, SINCE THE CAP WAS NOT RETURNED THE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. BASED ON THE INVESTIGATIONAL FINDINGS THE ROOT CAUSE IS UNDETERMINED DUE TO INSUFFICIENT INFORMATION, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. MONITOR COMPLAINTS THROUGH SEP-419. 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.

    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).

    Description of Event or Problem · 1

    METAL BACKED KEEL OSTEOTOME BROKE DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812678 SIGMA HP UNI FB KEEL OSTEOTOME KNEE INSTRUMENTS HWM DEPUY ORTHOPAEDICS, INC. 1818910 GM0909

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR