BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2018-54216

    MDR report key: 7723797 · Received July 26, 2018

    Report

    Report Number
    1221934-2018-54216
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    PMA / PMN Number
    K951702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. INVESTIGATION SUMMARY : THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEAL THAT ALL COMPONENTS ON THE RETURNED SHEATH ARE INTACT AND THERE ARE NO LOOSE OR BROKEN PARTS. WE CANNOT CONFIRM THIS COMPLAINT AT THIS POINT. 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 DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION IN 2010. THIS DEVICE IS 4 YEARS OLD AND PROBABLY HAS SEEN HEAVY USE. BASED ON THE OVERALL COMPLAINT RATE FOR THIS FAILURE MODE, AT THIS TIME, NO FURTHER ACTIONS ARE WARRANTED. HOWEVER, DEPUY 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. DEVICE HISTORY LOT : A CHECK OF THE MANUFACTURING FINISHED GOODS RECORDS FOR THE REPORTED BATCH NUMBER REVEALED NO ANOMALIES RELATING TO THE REPORTED INCIDENT. THERE WERE DEVICES RELEASED FOR DISTRIBUTION IN OCTOBER, 2010. THERE WERE NO ANOMALIES OR DISCREPANCIES IN THE MANUFACTURE OF THIS LOT. 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 SALES REP REPORTED THAT DURING A SHOULDER PROCEDURE THAT THE CUSTOMER'S HIGH FLOW SHEATH, STRYKER 5.9, BROKE WHERE IT ATTACHES TO THE TUBE OUTSIDE OF THE PATIENT. THE SALES REP REPORTED THAT NOTHING FELL INSIDE THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE AND WITH NO PATIENT CONSEQUENCE. THERE WAS A 15 MINUTE DELAY. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER BUT REPORTED THE DEVICE WAS OVER TWO YEARS OLD, WORN AND HAD SEEN HEAVY USE.

    Patients

    Seq Age Sex Outcome Treatment
    1