BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE F/ELECTRIC PEN DRIVE+SMALL ELECTRI

    MDR report key: 5529832 · Received March 28, 2016

    Report

    Report Number
    8030965-2016-12126
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 10, 2016
    Report Date
    March 10, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PK043310
    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 SERIAL NUMBER WAS DOCUMENTED AS (B)(4) ON THE INITIAL REPORT. UPON COMPLAINT REVIEW, IT WAS DETERMINED THAT THIS IS INCORRECT AS THE DEVICE HAS A LOT NUMBER OF 7872743 INSTEAD. THEREFORE, THE LOT NUMBER FIELD HAS BEEN UPDATED AS 7872743 TO REFLECT THE CORRECT INFORMATION. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING 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

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE WORKED WELL AND NO FAILURE COULD BE FOUND. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 5 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED VETERINARY SURGERY, IT WAS DISCOVERED THAT THE HANDPIECE DEVICE KEPT TURNING AFTER THE DOCTOR RELEASED THE MANUAL CONTROL. ACCORDING TO THE REPORT, THE DEVICE WAS IN USE WITH A CONSOLE DEVICE, TWO CABLE DEVICES AND A HAND SWITCH DEVICE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF SPARE DEVICES WERE AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS WAS A VETERINARY PROCEDURE. 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
    186572 CABLE F/ELECTRIC PEN DRIVE+SMALL ELECTRI INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 7872743

    Patients

    Seq Age Sex Outcome Treatment
    1