BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO INSCR SMALL SIZE 5X23

    MDR report key: 8265164 · Received January 21, 2019

    Report

    Report Number
    1221934-2018-52648
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010714
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THIS COMPLAINT IS BEING CLOSED SINCE AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE PRODUCT, THE PRODUCT STILL HASN'T BEEN RETURNED FOR EVALUATION. IF AND WHEN THE DEVICE IN QUESTION IS RECEIVED, THIS FILE WILL BE REOPENED AND ITS CONTENTS MADE TO REFLECT THE RESULTS OF THE EVALUATION. A REVIEW INTO THE DEPUY 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. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 231803, LOT #3897569 COMBINATION. A (B)(4) WAS IDENTIFIED, NONETHELESS THE COMPLAINT CONDITION IS UNRELATED TO THE NONCONFORMANCE. 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. 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 (B)(4) 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 BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 5X23 DEVICE BROKE. ACCORDING TO THE REPORTER, THE PROCEDURE WAS PERFORMED WITH EXTERNAL GRAFT. IT WAS FURTHER REPORTED THAT THE EVENT OCCURRED WHEN THE DOCTOR TRIED TO SCREW THE DEVICE IN THE FEMORAL SIDE (TUNNEL 6MM, GRAFT 5MM) BUT AFTER A FEW ROUNDS THE SCREW BROKE (THE DOCTOR WAS IN THE AXIS OF THE TUNNEL AND HE USED THE PIN GUIDE REF 254514). THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. 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
    58224 MILAGRO INSCR SMALL SIZE 5X23 ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK LLC US 3897569 10886705010714

    Patients

    Seq Age Sex Outcome Treatment
    1