BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRIFXQA+ W/#4OC P3

    MDR report key: 13177959 · Received January 6, 2022

    Report

    Report Number
    1221934-2022-00041
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 10, 2021
    Report Date
    January 6, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705001897
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: UDI: (B)(6) INVESTIGATION SUMMARY : THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (6L75664), AND NO NON-CONFORMANCE WAS IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT POSTOPERATIVELY ON (B)(6) 2021 DURING BANDAGING OF THE FIXATION FROM AN UNKNOWN SURGERY INITIALLY PERFORMED ON (B)(6) 2021, IT WAS DETECTED THROUGH X-RAY THAT THERE WERE INSOLVENCIES OF FIXATION USING THE MICRIFXQA+ W/#4OC P3 ANCHOR DEVICE AS THE THREAD LOST ITS INTEGRITY. ACCORDING TO THE REPORT, THE SECOND OPERATION WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE BROKEN SUTURE BUT THE ANCHOR COULD NOT BE REMOVED AND IT REMAINED IN THE PATIENT. THE STATUS OF THE PATIENT WAS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666405 MICRIFXQA+ W/#4OC P3 SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 212044 6L75664 10886705001897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention