BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENISCAL DEPLOYMENT GUN

    MDR report key: 8254387 · Received January 16, 2019

    Report

    Report Number
    1221934-2019-56021
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEF
    UDI-DI
    10886705010059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4) - INCOMPLETE. THE EXP DATE IS CURRENTLY UNAVAILABLE. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE (B)(4), LOT 3860971 COMBINATION AND NO NON-CONFORMANCE'S WERE IDENTIFIED. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS REPORT IS BEING FILED FROM THE ETQ 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

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING A MENISCAL REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE PUSHER ROD ON HIS OMNISPAN MENISCAL APPLIER BECAME STUCK UNDER THE NEEDLE AFTER FIRING THE SECOND IMPLANT. THE SURGEON COULD NOT GET THE ROD TO RETRACT AND COMPLETED THE PROCEDURE WITH A COMPETITOR'S DEVICE WITH A 20 MINUTE DELAY IN THE SURGICAL PROCEDURE. THE SALES REP REPORTED THAT BOTH OF THE OMNISPAN IMPLANTS WERE LEFT SECURED WITHIN THE MENISCUS. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED. 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
    47900 MENISCAL DEPLOYMENT GUN ORTHOPAEDIC CERCLAGE APPLIER GEF DEPUY MITEK LLC US 3860971 10886705010059

    Patients

    Seq Age Sex Outcome Treatment
    1