BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO ADVANCE SCREW 7X23MM

    MDR report key: 8518349 · Received April 16, 2019

    Report

    Report Number
    1221934-2019-56859
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 20, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705022243
    PMA / PMN Number
    K143660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 CONCLUSION 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NR-0090833 WAS IDENTIFIED FOR THIS LOT NUMBER. THE COMPLAINT CONDITION IS UNRELATED TO THE NON-CONFORMANCE. 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. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS AN UNKNOWN DATE IN (B)(6) 2019. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE THAT DURING A LIGAMENTOPLASTY BTB THE MILAGRO ADVANCE BROKE ON THE SECOND BOLT TURN. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WERE ANY SURGICAL DELAY, MEDICAL INTERVENTION PLANNED, OR IF THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313664 MILAGRO ADVANCE SCREW 7X23MM ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK LLC US 231816 L705405 10886705022243

    Patients

    Seq Age Sex Outcome Treatment
    1