BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRI SHORT HD ATTACHMENT

    MDR report key: 4090618 · Received September 15, 2014

    Report

    Report Number
    1045834-2014-12867
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    PK061297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE PASSED ALL OPERATIONAL SPECIFICATIONS. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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

    THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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 2 OF 2 OF THE SAME EVENT IT WAS REPORTED THAT DURING CRANIOTOMY SURGERY, IT WAS OBSERVED THAT THE MOTOR DEVICE AND THE ATTACHMENT DEVICE WOULD NOT LOAD THE BURR DEVICE CORRECTLY WHEN IN USE TOGETHER. IT WAS FURTHER CLARIFIED THAT THE BURR DEVICE WOULD NOT LOCK INTO PLACE. AS A RESULT, THERE WAS A TEN MINUTE EXTENSION TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE AND THE SURGICAL PROCEDURE WAS WHICH COMPLETED SUCCESSFULLY WITH A SPARE DEVICE. 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
    570202 IMRI SHORT HD ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MOTOR DEVICE| BURR DEVICE