BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY DEVICE

    MDR report key: 6017700 · Received October 11, 2016

    Report

    Report Number
    1045834-2016-12917
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 23, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 27 OF 27 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT SIX OSCILLATING DEVICES AND BATTERY REAMER/DRILL DEVICES WERE NOT FUNCTIONING AS THEY SHOULD WHEN USED WITH 19 BATTERY DEVICES AND TWO UNIVERSAL BATTERY CHARGER DEVICES. IT WAS REPORTED THAT THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE AND AN UNSPECIFIED SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO PATIENT OR USER INJURIES REPORTED. IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    670282 BATTERY DEVICE BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY CHARGER DEVICES| BATTERY DEVICES| BATTERY REAMER/DRILL DEVICES| OSCILLATOR DEVICES