BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA HP UNI FB KEEL OSTEOTOME

    MDR report key: 1945195 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09800
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED INSTRUMENT FOUND THE PRODUCT TO MEET DIMENSIONAL SPECIFICATIONS AND THE METAL GOUGE FEATURE TO BE SHARP AS DESIGN INTENDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED FRACTURED PT TIBIAL PLATE. A SEARCH OF THE COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS AGAINST PRODUCT CODE 202447111 ASSOCIATED WITH TIBIAL PLATEAU FRACTURES OR DULL OSTEOTOMES. NO EVIDENCE WAS FOUND OF PRODUCT ERROR AS 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 INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE METAL-BACKED KEEL OSTEOTOME WAS CONSIDERED DULL AND WHEN IN USE CAUSED A POSTERIOR TIBIAL PLATEAU FRACTURE, WHICH WAS FIXED WITH CANNULATED SCREWS. THIS ALSO CAUSED A 30-MINUTE SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA HP UNI FB KEEL OSTEOTOME 87LXH LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC. NA GM0708

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention