BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3854108 · Received May 12, 2014

    Report

    Report Number
    1319774-2014-00001
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Product Code
    GEI
    PMA / PMN Number
    K103375
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THE BLADE BROKE DUE TO AN UNK STRESS OR OVER-TORQUE EVENT. PHYSICIAN EITHER TRIED TO BEND THE BLADE OR FORCIBLY STRUCK A BONE CAUSING THE BLADE TO SHEAR OFF. NO OTHER REPORTS OF THE BLADE BREAKING DURING USE, EXCEPT WHEN PHYSICIANS INTENTIONALLY TRIED TO BEND THE BLADE. THE BLADE IS NOT INTENDED TO BE BENT.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283508 NONE GEI

    Patients

    Seq Age Sex Outcome Treatment
    1