BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO/ASIF-QC F/BPL

    MDR report key: 4961828 · Received August 3, 2015

    Report

    Report Number
    8030965-2015-11298
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    July 6, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT IT WAS DEFORMED, BENT AND THE DRILLS DID NOT HOLD. FURTHERMORE, IT WAS OBSERVED THE TOOL SIDE WAS DAMAGED, THE COUPLING SLEEVE WAS JAMMED AND THE DRILL CHUCK HAD DROPPED DOWN. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO FAULTY/IMPROPER HANDLING. 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

    REPORTER NUMBER: (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 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 FROM (B)(6) THAT THE HEAD WAS WORN OUT ON THE BURR ATTACHMENT DEVICE OUT AND THEREFORE THE DEVICE DID NOT FUNCTION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS NOT AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY 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
    505638 AO/ASIF-QC F/BPL MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY SYNTHES OBERDORF NA

    Patients

    Seq Age Sex Outcome Treatment
    1