BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2018-52033

    MDR report key: 7710692 · Received July 23, 2018

    Report

    Report Number
    1221934-2018-52033
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Report Date
    June 4, 2014
    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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONC LUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. VISUAL OBSERVATION REVEALS THAT THE HANDLE AND SPRING ARE MISSING. THE THREADS ON THE VALVES ARE WORN AND CANNOT BE CONNECTED INTO THE SHEATH. THE SHEATH ITSELF LOOKS WORN WITH NICKS AND MARKS AND THE DISTAL EDGE SLIGHTLY BENT CONSISTENT WITH IT BEING USED. REPEATED USE AND STERILIZATION CYCLES CAN LEAD TO THIS TYPE OF FAILURE AND THEREFORE CAN BE ATTRIBUTED TO FIELD WEAR. OTHER THAN THIS POSSIBILITY, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE. FURTHERMORE, A LOT REVIEW WAS NOT AVAILABLE IN SPITE OF THREE REQUESTS SENT OUT TO THE SUPPLIER. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS 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. CORRECTED DATA: THIS COMPLAINT WAS INADVERTENTLY INCORRECTLY REPORTED AS A SERIOUS INJURY. THIS COMPLAINT IS A PART OF MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. THIS WILL BE REPORTED AS A MALFUNCTION. 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.

    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. THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. VISUAL OBSERVATION REVEALS THAT THE HANDLE AND SPRING ARE MISSING. THE THREADS ON THE VALVES ARE WORN AND CANNOT BE CONNECTED INTO THE SHEATH. THE SHEATH ITSELF LOOKS WORN WITH NICKS AND MARKS AND THE DISTAL EDGE SLIGHTLY BENT CONSISTENT WITH IT BEING USED. REPEATED USE AND STERILIZATION CYCLES CAN LEAD TO THIS TYPE OF FAILURE AND THEREFORE CAN BE ATTRIBUTED TO FIELD WEAR. OTHER THAN THIS POSSIBILITY, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE. FURTHERMORE, A LOT REVIEW WAS NOT AVAILABLE IN SPITE OF THREE REQUESTS SENT OUT TO THE SUPPLIER. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS 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. 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

    IT WAS REPORTED THAT THE BIOMED FROM THE FACILITY REPORTED THE HANDLE IN THEIR 5.9MM LINVATEC HIGH FLOW SHEATH BROKE OFF AND THE SPRING FELL OUT PRIOR TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. THE SURGEON USED ANOTHER SHEATH TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS COMING BACK FOR EVALUATION. NO FURTHER DETAILS WERE AVAILABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1