BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER DRIVE

    MDR report key: 5972695 · Received September 23, 2016

    Report

    Report Number
    8030965-2016-14761
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Report Date
    June 9, 2016
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). 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

    CORRECTION: IT WAS INITIALLY REPORTED THAT THE DEVICE HAD A CAUSE CODE OF ECB - LABEL/ID/PACKAGING WRONG AND DAMAGED. IT WAS LATER DETERMINED THAT THIS WAS ENTERED IN ERROR AND HAS BEEN UPDATED TO REFLECT THE CORRECT CODE. THE DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED THAT THE TRIGGER WAS BROKEN AND THE REVERSE TRIGGER WAS BROKEN. IT WAS FURTHER REPORTED THAT THE DEVICE FAILED PRE-TEST FOR TRIGGERS AND ELECTRONIC CONTROL UNIT. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS OBSERVED THAT THE TRIGGER ON THE POWER DRIVE DEVICE WAS BROKEN. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD A BROKEN REVERSE TRIGGER AND A CAUSE CODE ECB-LABEL/ID/PACKAGING WAS WRONG AND DAMAGED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRE-TEST FOR TRIGGER AND ECU FUNCTIONS. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    626928 POWER DRIVE MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES OBERDORF NA

    Patients

    Seq Age Sex Outcome Treatment
    1