BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINCISE SURGICAL IMPACTOR

    MDR report key: 8621640 · Received May 17, 2019

    Report

    Report Number
    1045834-2019-53631
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    May 9, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    00850915006006
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE DATE OF MANUFACTURE WAS REPORTED AS UNKNOWN IN THE INITIAL REPORT. THE DATE HAS BEEN UPDATED TO 8/27/2018. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. QUALITY ENGINEERING EVALUATED THE DEVICE AND IT WAS DETERMINED THAT THE DEVICE PASSED ALL FUNCTIONAL AND VISUAL SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THE DATE OF MANUFACTURE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KINCISE SURGICAL IMPACTOR DEVICE WAS MISFIRING. THE REPORTER INDICATED THAT THEY WERE NOT SURE IF THE ISSUE WAS RELATED TO THE HANDPIECE OR THE BATTERY DEVICES. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413867 KINCISE SURGICAL IMPACTOR MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES PRODUCTS LLC 00850915006006

    Patients

    Seq Age Sex Outcome Treatment
    1