BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASING FOR 14.4V BATTERY

    MDR report key: 4791634 · Received May 22, 2015

    Report

    Report Number
    3009450871-2015-11624
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    August 1, 2014
    Report Date
    August 21, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD CORROSION ON THE CONTACTS. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMMERSION DURING CLEANING. 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

    IT WAS REPORTED THAT THE CASING FOR BATTERY DEVICE WAS NOT WORKING. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE REPORTER STATED THAT THE EVENT OCCURRED ON (B)(6) 2014; HOWEVER, 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
    336368 CASING FOR 14.4V BATTERY BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS 005552

    Patients

    Seq Age Sex Outcome Treatment
    1