BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESS FACE REAMER LARGE

    MDR report key: 4093794 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07747
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    May 12, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND EVIDENCE OF PRODUCT NON-CONFORMANCE. CORRECTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THE REPORTED ISSUE. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. INITIAL REPORTER - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014 THAT THE REAMER WAS STRAIGHT AND DID NOT HAVE THE BEVEL AS REQUIRED. THIS ISSUE WAS NOTED PRIOR TO A PROCEDURE AND THE INSTRUMENT WAS NOT ATTEMPTED FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573732 COMPRESS FACE REAMER LARGE REAMER HTO BIOMET ORTHOPEDICS N/A 392410

    Patients

    Seq Age Sex Outcome Treatment
    1