BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 6416918 · Received March 20, 2017

    Report

    Report Number
    1045834-2017-10685
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 27, 2017
    Report Date
    February 27, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PART NUMBER AS UNKNOWN. ALL ATTEMPTS TO OBTAIN PRODUCT INFORMATION WERE UNSUCCESSFUL. THEREFORE, UDI IS UNAVAILABLE. THE BRAND NAME IS UNKNOWN. THE CATALOG NUMBER, LOT/SERIAL NUMBER IS UNKNOWN. THE PMA/510(K) NUMBER IS UNKNOWN. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS UNKNOWN. (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

    ADDITIONAL NARRATIVE: (B)(4). THE PRODUCT CODE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT AND HAS BEEN UPDATED TO SC2100. THEREFORE, THE BRAND NAME, COMMON DEVICE, DEVICE PRODUCT CODE, AND CATALOG NUMBER HAVE BEEN UPDATED ACCORDINGLY. THE SERIAL NUMBER WERE DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT AND HAVE BEEN UPDATED AS (B)(4) AND (B)(4) RESPECTIVELY. UPDATED AS K080802. THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT AND HAS BEEN UPDATED AS OCT 21, 2010. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR IT WAS DETERMINED THAT THE REPORTED CONDITION OF THE DEVICE FAN MAKING RATTLING NOISE COULD NOT BE CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD A GROUND LUG BROKEN OFF THE AC INPUT MODULE WHICH PREVENTED THE PRETEST FROM BEING COMPLETED. IT WAS DETERMINED THAT THIS WAS DUE TO WEAR FROM NORMAL USE AND SERVICING OVER TIME. 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 FOR THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED MAJOR EAR SURGERY, IT WAS OBSERVED THAT THE CONSOLE DEVICE AND THE MOTOR DEVICE W BEGAN MAKING A RATTLING NOISE LIKE THE FAN BEARING WAS ON ITS WAY TO STOPPING WHILE IN USE TOGETHER. ACCORDING TO THE REPORT, AN E6 ERROR CODE (OVERHEATING) APPEARED ON THE CONSOLE DEVICE WHILE THE MOTOR DEVICE BECAME EXTREMELY HOT TO HANDLE. AS A RESULT, THERE WAS A 20 MINUTE DELAY TO THE SURGICAL PROCEDURE IN ORDER TO OBTAIN A SPARE DEVICE TO COMPLETE THE SURGERY. 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
    201105 SYSTEM CONSOLE MOTOR, DRILL, ELECTRIC - CONSOLE HBC DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 MOTOR DEVICE