BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR REAMER/DRILL

    MDR report key: 3964877 · Received July 29, 2014

    Report

    Report Number
    8030965-2014-10435
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE AIR/REAMER MOTOR DEVICE HAD AN UNSPECIFIED MALFUNCTION. IT WAS REPORTED THAT THERE WAS A DELAY OF LESS THAN THIRTY MINUTES TO THE SURGICAL PROCEDURE. THE AMOUNT OF DELAY WAS NOT SPECIFIED. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED BY HAND REAM; IT WAS NOT SPECIFIED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF 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
    442412 AIR REAMER/DRILL INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE SYNTHES OBERDORF 00834

    Patients

    Seq Age Sex Outcome Treatment
    1