BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLUBE-III WITH MA7

    MDR report key: 6142033 · Received December 2, 2016

    Report

    Report Number
    1045834-2016-13333
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Report Date
    October 10, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    K970530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: GTIN IS UNAVAILABLE AS THE PRODUCT MADE PRIOR TO COMPLIANCE DATE; (B)(4). INITIAL REPORTER¿S PHONE NUMBER: (B)(6). THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE AND SERVICING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DISCOVERED THAT THERE WAS OIL LEAK ON THE FOOT CONTROL DEVICE. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD OIL LOSS, THE WINKLE ADAPTER WAS LOOSE AND DEFECTIVE AND THE HOSE WAS WORN OUT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED FOR DRIP RATE ASSESSMENT. 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
    793660 AUTOLUBE-III WITH MA7 MOTOR, SURGICAL INSTRUMENT, AC-POWERED - FOOT CONTROL GEY DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1