BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 7464023 · Received April 26, 2018

    Report

    Report Number
    1043214-2018-00001
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    November 24, 2017
    Report Date
    April 25, 2018
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    GES
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL INDUSTRIES, INC. RECEIVED NOTIFICATION FROM THE FDA OF A MEDWATCH REPORT (MW5073708) RECEIVED THROUGH ITS FDA MEDWATCH PROGRAM. THIS NOTIFICATION WAS RECEIVED BY A DEROYAL REPRESENTATIVE ON (B)(6) 2017. THE INFORMATION RECEIVED BY DEROYAL DID NOT INCLUDE SUFFICIENT INFORMATION TO OPEN A COMPLAINT INVESTIGATION. INFORMATION LACKING INCLUDED A DEVICE MODEL NUMBER, LOT NUMBER, AND THE INITIAL REPORTER'S NAME AND CONTACT. IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION, DEROYAL OPENED A CORRECTIVE AND PREVENTIVE ACTION INVESTIGATION (B)(4). ULTIMATELY, NO ADDITIONAL INFORMATION COULD BE OBTAINED AND NO ROOT CAUSE COULD BE DETERMINED. DEROYAL DISTRIBUTES SCALPEL BLADES. IT DOES NOT MANUFACTURE OR HOLD DESIGN SPECIFICATIONS FOR THE BLADES. WITHOUT A DEVICE MODEL NUMBER, DEROYAL IS UNABLE TO DETERMINE THE SUPPLIER THAT MANUFACTURED THE DEFECTIVE BLADE. THEREFORE, THIS MEDICAL DEVICE REPORT IS BEING REPORTED UNDER THE DEROYAL ESTABLISHMENT RESPONSIBLE FOR COMPLAINT HANDLING. IF NEW AND CRITICAL INFORMATION IS RECEIVED, DEROYAL WILL REOPEN ITS INVESTIGATION AND UPDATE THIS REPORT.

    Description of Event or Problem · 1

    A #15 SCALPEL BLADE FRACTURED DURING SURGICAL PROCEDURE. REQUIRED USE OF FLUOROSCOPIC TO LOCATE REMAINING PIECE IN RIGHT FOOT 1ST MPJ AREA. CAUSED A 30-MINUTE DELAY LOCATING SCALPEL FRAGMENT. PIECE WAS LOCATED AND REMOVED. DIAGNOSIS OR REASON FOR USE: BUNIONECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309997 DEROYAL BLADE, SCALPEL GES DEROYAL INDUSTRIES, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other