BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR OSCILLATOR

    MDR report key: 6331510 · Received February 15, 2017

    Report

    Report Number
    8030965-2017-10789
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 26, 2017
    Report Date
    January 30, 2017
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (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 ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    CORRECTION: UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT MFR# 8030965 --2017-10789 IS A DUPLICATE OF MFR# 8030965 -2017-10790. REFERENCE MFR# 8030965 -2017-10790 FOR ALL FURTHER REPORTING REGARDING THIS EVENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE AIR OSCILLATOR DEVICE MOTOR OSCILLATED AND THE SAW WAS NOT ABLE TO CUT THE BONE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO THE SURGICAL PROCEDURE OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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
    114137 AIR OSCILLATOR INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF NA

    Patients

    Seq Age Sex Outcome Treatment
    1