BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER MODULE F/TRS

    MDR report key: 6103188 · Received November 15, 2016

    Report

    Report Number
    8030965-2016-15579
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 1, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4). 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

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A CRACK ON THE NECK AND HAD DEFECTS OF THE HOUSING. THE INVESTIGATION RESULTS SHOWED THAT THE DEVICE WAS DAMAGED BY DROPPING. IT WAS FURTHER OBSERVED THAT THE SURFACE OF THE HOUSING WAS DAMAGED BY ENGRAVING ADDITIONAL SIGNS (SERIAL NUMBERS). THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, WHICH IS USER ERROR/MISUSE/ABUSE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, 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 DURING A PRIMARY HIP REPLACEMENT SURGERY, IT WAS DISCOVERED THAT THE POWER OF THE BATTERY DEVICE DECREASED TO 75%. IT WAS FURTHER REPORTED THAT THE HANDPIECE DEVICE AND THE POWER MODULE DEVICE WERE HEATING UP AND HAD A HIGH TEMPERATURE. ACCORDING TO THE REPORTER, THE BATTERY DEVICE WAS CHECKED BEFORE STARTING THE SURGERY AND IT WAS REPORTED TO BE FULLY CHARGED. HOWEVER, DURING SURGERY, AT THE FIRST USE OF THE MOTOR, THE MOTOR OUTPUT BEGAN TO DECREASE AND THE STATE OF THE BATTERY WAS 75%. IT WAS REPORTED THAT THE BATTERY DEVICE WAS REMOVED, VERIFIED, REASSEMBLED AND THEN USED. HOWEVER, IT WAS NOT POSSIBLE TO COMPLETE THE CUT AS THE DEVICE HAD NO POWER. ACCORDING THE REPORTER, THE MOTOR OF THE BATTERY WAS FOUND TO BE 50% LESS THAN THE LOAD. THE REPORTER INDICATED THAT DIFFERENT MODES/FUNCTIONS WERE TRIED, BUT THE MOTOR OF THE POWER MODULE DEVICE DID NOT RESPOND. IT WAS FURTHER REPORTED THAT THE HANDPIECE MOTOR AND BATTERY (POWER MODULE) WERE HEATING UP. IT WAS REPORTED THAT THE DEVICES WERE WORKING PRE-OPERATIVELY, BUT STOPPED WORKING DURING THE SURGERY. THERE WAS A THIRTY MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT ANOTHER STERILE MOTOR DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS REPORTED THAT THERE WAS NO ADVERSE EFFECT ON THE PATIENT OR USER AND THE PATIENT OR USER WERE NOT BURNT AS A RESULT OF THE DEVICES OVERHEATING. 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
    755475 POWER MODULE F/TRS BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 BATTERY DEVICE| BATTERY HANDPIECE DEVICE