BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION THIN SAGITTAL BLADE

    MDR report key: 8623324 · Received May 20, 2019

    Report

    Report Number
    8623324
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 26, 2019
    Report Date
    April 26, 2019
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS IN THE PROCESS OF HARVESTING THE PATELLA BONE-TENDON-BONE AUTOGRAFT WITH THE USUAL STRYKER BLADE # 2296-003-111. LOT# 19055037, EXP: 2024-03-01. THE BLADE BROKE WHILE IN USE. DR. IMMEDIATELY STOPPED USING IT AND WE REPLACED IT WITH A NEW ONE TO FINISH THE HARVEST. NO APPARENT HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419107 PRECISION THIN SAGITTAL BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA STRYKER ENDOSCOPY 2296-003-111 19055037

    Patients

    Seq Age Sex Outcome Treatment
    1 10220 DA