BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY H&PIECE/MOD FOR TRAUMA RECON SYS

    MDR report key: 11583941 · Received March 29, 2021

    Report

    Report Number
    8030965-2021-02403
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 17, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    UDI-DI
    07611819977815
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: THIS DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, DURING PRE-REPAIR ASSESSMENT, IT WAS DETERMINED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. H6. MEDICAL DEVICE PROBLEM CODE: IT WAS REPORTED THAT THE DEVICE EXHIBITED INTERMITTENT OPERATION (A070802). UPON SUBSEQUENT FOLLOW-UP WITH THE REPORTER, IT WAS DETERMINED THAT THE DEVICE CODE A070802 WAS REPORTED IN ERROR. THE CORRECT MEDICAL DEVICE CODE TO REFLECT THE REPORTED FAILURE HAS BEEN UPDATED TO A070801 - COMPLETE LOSS OF POWER.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. CONCOMITANT MED PRODUCTS: BATTERY DEVICE. UDI (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ENGINE OF THE BATTERY HANDPIECE DEVICE BEGAN TO WARM UP AND ONE FROM MOMENT TO ANOTHER THE DEVICE WOULD STOP WORKING. ACCORDING TO THE REPORTER, WHEN THE BATTERY WAS CHECKED, IT WAS NOTED THAT THE BATTERY HAD DISCHARGED. IT WAS NOT REPORTED IF THERE WAS DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481065 BATTERY H&PIECE/MOD FOR TRAUMA RECON SYS MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES GMBH 07611819977815

    Patients

    Seq Age Sex Outcome Treatment
    1