BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT F/532.001+532.010 14.4VDC

    MDR report key: 4220964 · Received November 3, 2014

    Report

    Report Number
    3009450871-2014-10566
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND THE DEVICE PASSED SPECIFICATIONS. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    REPORTER¿S NAME AND PHONE NUMBER WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    DURING SUBSEQUENT FOLLOW-UP WITH THE REPORTER, ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THE BATTERY WOULD NOT HOLD CHARGE. 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 1 OF 6 OF THE SAME EVENT. IT WAS REPORTED FROM NETHERLANDS THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BATTERY DEVICE WAS NOT FUNCTIONING AS EXPECTED. ACCORDING TO THE REPORTER, TWO BATTERIES WERE NEEDED FOR ONE OPERATING ROOM. THE REPORTER COULD NOT PROVIDE A SPECIFIC NUMBER OF OCCURRENCES OR SPECIFIC NUMBER OF DEVICES INVOLVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS 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
    702521 BATT F/532.001+532.010 14.4VDC BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS D120615

    Patients

    Seq Age Sex Outcome Treatment
    1