BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA

    MDR report key: 3994376 · Received August 8, 2014

    Report

    Report Number
    1045834-2014-12605
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    July 24, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FAILED CONNECTOR RESISTANCE. IT WAS DETERMINED THAT THIS FAILURE COULD CAUSE INTERMITTENT OPERATION. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE MOSTLY LIKELY DUE TO THE RESISTOR GOING BAD DUE TO NORMAL WEAR FROM USE AND SERVICING. 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 WAS RETURNED AND IS PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATED THE DEVICE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 THE CONSOLE DEVICE EXPERIENCED INTERMITTENT OPERATION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. THE REPORTER STATED THE EVENT ¿KEEPS HAPPENING¿. HOWEVER, THE REPORTER WAS UNABLE TO PROVIDE A SPECIFIC NUMBER OF OCCURRENCES. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467610 SYSTEM CONSOLE,SINGLE PORT,W/IRRIGA MOTOR, DRILL, ELECTRIC - CONSOLE HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1