BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT F/BPL 14.4VDC

    MDR report key: 4240642 · Received November 10, 2014

    Report

    Report Number
    3009450871-2014-10595
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 28, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE CONTROL UNIT WAS NOT FUNCTIONING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (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 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BATTERY REAMER DRILL DEVICE OVERHEATED AND STOPPED FUNCTIONING. ACCORDING TO THE REPORTER, THE DEVICE WAS THEN SWITCHED OFF AND ON AGAIN. HOWEVER, THE DEVICE WAS STILL NOT FUNCTIONING. THE REPORTER INDICATED THAT THE BATTERY INSIDE THE CASING WAS CHECKED AND IT WAS FOUND THAT PART OF THE BATTERY HOUSING WAS MELTED. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, 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
    723368 BATT F/BPL 14.4VDC MOTOR, DRILL, PNEUMATIC HBB DEPUY SYNTHES POWER TOOLS D110325

    Patients

    Seq Age Sex Outcome Treatment
    1