BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY F/NOS. 532.101+532.110

    MDR report key: 4781432 · Received May 19, 2015

    Report

    Report Number
    3009450871-2015-11578
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Report Date
    October 7, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE WAS NOT CHARGING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO FAULTY MATERIAL. 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 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT TWO BATTERY DEVICES DID NOT LOAD WHILE IN USE TOGETHER. IT WAS UNKNOWN TO THE REPORTER IF THE DEVICE WAS USED IN SURGERY. IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. 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
    324302 BATTERY F/NOS. 532.101+532.110 INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 130117

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY DEVICE