BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2018-53699

    MDR report key: 7756930 · Received August 7, 2018

    Report

    Report Number
    1221934-2018-53699
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    PMA / PMN Number
    K951702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THE REPORTED BROKEN PART IS THE KNOB THAT IS USED TO LOCK/UNLOCK THE SHEATH. THE KNOB WAS SENT BACK WITH THE DEVICE. IT WAS INSPECTED AND NO ANOMALIES WERE FOUND; IT WAS SCREWED BACK TO THE DEVICE WITH NO DIFFICULTY. THE REPORTED FAILURE CANNOT BE BROKEN. ONE POSSIBLE HYPOTHESIS IS THAT AFTER CLEANING THE DEVICE, THE USER DID NOT KNOW HOW TO SCREW THE KNOB BACK. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS FROM THIS LOT RELEASED FOR DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. THIS REPORT IS BEING FILED FROM THE REMETREX COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER'S BIOMEDICAL TECHNICIAN REPORTED THAT FOLLOWING AN UNKNOWN SURGERY, THE HANDLE ON THEIR LINVATEC HIGH FLOW SHEATH WAS BROKEN OFF THE DEVICE. THE TECHNICIAN CONFIRMED THE PART THAT BROKE OFF WAS OUTSIDE THE PATIENT. THE TECHNICIAN COULD NOT PROVIDE ANY FURTHER INFORMATION BUT REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAY IN PROCEDURE.

    Patients

    Seq Age Sex Outcome Treatment
    1