BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTOLOGIC CURVED MICRO ATTACHMENT

    MDR report key: 4180963 · Received October 17, 2014

    Report

    Report Number
    1045834-2014-14635
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    PK131053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS UNKNOWN. THEREFORE, THE DATE OF MANUFACTURE WAS UNKNOWN. 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

    THIS IS REPORT 4 OF 5 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT THE CUTTING BURR DEVICE DID NOT ENGAGE PROPERLY INTO THE ATTACHMENT DEVICE. ACCORDING TO THE REPORT, THE CUTTING BURR DID PROPERLY ENGAGE INTO THE ATTACHMENT DEVICE SOMETIMES; AND AT OTHER TIMES IT WOULD EITHER PARTIALLY ENGAGE OR NOT ENGAGE AT ALL. THE REPORTER STATED THAT WHEN THE BURR WAS PARTIALLY ENGAGED, THE BURR WOULD NOT ROTATE WHEN THE FOOT PEDAL WAS PRESSED; AND WOULD EVENTUALLY FALL OUT COMPLETELY. THE REPORTER STATED THAT THIS ISSUE WAS PRESENT IN ALL FOUR ATTACHMENT DEVICES THAT WERE USED. THE REPORTER STATED THAT CUTTING BURR DEVICE WAS CHANGED AND THE SAME ISSUE WAS OBSERVED. THERE WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE AVAILABLE FOR USE. 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
    662608 OTOLOGIC CURVED MICRO ATTACHMENT DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1