BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 5854739 · Received August 8, 2016

    Report

    Report Number
    8030965-2016-14445
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 27, 2016
    Report Date
    July 27, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR SERVICE, HOWEVER DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE UPPER TRIGGER WAS STICKING. IT WAS FURTHER OBSERVED THAT THE DEVICE FAILED THE COUPLING ATTACHMENT TEST (WOULD NOT ENGAGE THE RPT-0000070 GAUGE). IT WAS OBSERVED THAT THE ELECTRONIC CONTROL UNIT (ECU) CONTACTS WERE CORRODED. IT WAS FURTHER OBSERVED THAT THE UPPER TRIGGER COMPONENTS AND THE COUPLING HEAD WERE WORN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE OVER TIME 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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS DISCOVERED THAT THE SMALL BATTERY DRIVE DEVICE FAILED THE ATTACHMENT COUPLING TEST AND THE UPPER TRIGGER WAS STICKING. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. 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
    505784 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 001614

    Patients

    Seq Age Sex Outcome Treatment
    1