BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANAL REAMER 13.5

    MDR report key: 1002219 · Received February 20, 2008

    Report

    Report Number
    1818910-2008-00254
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 21, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HTO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE INSTRUMENT WAS NOT RETURNED. THE INVESTIGATION IS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORT. A TWO-YEAR COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTS OF ANY KIND AGAINST THE PROVIDED PRODUCT CODE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR/CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    DURING SURGERY, REAMER BECAME STUCK AND THE DOCTOR HAD TO PERFORM AN OSTEOTOMY TO REMOVE IT, RESULTING IN A FIVE-HOUR EXTENSION OF SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANAL REAMER 13.5 87LXH HTO DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention