BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL REPAIR 12DEG

    MDR report key: 8261797 · Received January 18, 2019

    Report

    Report Number
    1221934-2018-52140
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    July 25, 2016
    Report Date
    July 25, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010035
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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). 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 OF ANY KIND 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 228141, LOT 3882291 COMBINATION AND NO NON-CONFORMANCES 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 AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ACL/MENISCUS REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SECOND ANCHOR WOULD START TO DEPLOY WHEN USING THE CUSTOMER'S OMINSPAN MENISCAL REPAIR 12 DEGREE AND THE CUSTOMER'S MENISCAL DEPLOYMENT GUN BEFORE THE FIRST IMPLANT WOULD DEPLOY. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH OTHER LIKES DEVICES WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY. THE SALES REP STATED THAT THEY ARE UNSURE IF THE GUN IS AT FAULT OR THE IMPLANTS. 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
    52626 OMNISPAN MENISCAL REPAIR 12DEG ORTHOPAEDIC CERCLAGE APPLIER MAI DEPUY MITEK LLC US 3882291 10886705010035

    Patients

    Seq Age Sex Outcome Treatment
    1