BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE 12V BATTERY

    MDR report key: 5273940 · Received December 8, 2015

    Report

    Report Number
    2520274-2015-17695
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Report Date
    November 30, 2015
    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

    SERIAL/LOT NUMBER IS UNKNOWN, THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. (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.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: THE DEVICE LOT NUMBER WAS NOT PROVIDED BY THE REPORTER IN THE INITIAL REPORT. THEREFORE, THE LOT NUMBER AND MANUFACTURE DATE WAS DOCUMENTED AS UNKNOWN. UPON RECEIPT OF THE DEVICE THE LOT NUMBER WAS IDENTIFIED AS D140407. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE (B)(4) EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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

    PRODUCT CATALOG NUMBER AND BRAND NAME: THE PRODUCT BRAND NAME WAS INCORRECTLY DOCUMENTED AS SMALL BATTERY DRIVE 14.4 VOLT LITHIUM ION BATTERY IN THE INITIAL REPORT. THE PRODUCT BRAND NAME HAS BEEN UPDATED TO SMALL BATTERY DRIVE 12V BATTERY. THE PRODUCT CATALOG NUMBER WAS INCORRECTLY DOCUMENTED AS 532.103 IN THE INITIAL REPORT. THE PRODUCT CATALOG NUMBER HAS BEEN UPDATED TO 532.003. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THAT THE DEVICE WAS SHORT CIRCUITED. IT WAS FURTHER OBSERVED THAT THERE WERE SOME BURNT SIGNS THAT WERE VISIBLE ON THE CONTACTS. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) BEFORE SURGERY, IT WAS DISCOVERED THAT THE SMALL BATTERY DEVICE FAILED IN DEVICE AND FAILED TO CHARGE AT ALL DESPITE TRYING WITH DIFFERENT CHARGERS AND TECHNIQUES. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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
    805901 SMALL BATTERY DRIVE 12V BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS D140407

    Patients

    Seq Age Sex Outcome Treatment
    1