BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILOK QA+ # 2-0 OC V5

    MDR report key: 10661478 · Received October 12, 2020

    Report

    Report Number
    1221934-2020-02947
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    September 23, 2020
    Report Date
    September 23, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705002429
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION: B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A DELAY OF 15 MINUTES IN THE PROCEDURE. IT WAS REPORTED THAT NO ADDITIONAL ANCHORS WERE USED. IT WAS REPORTED THAT A NEW BONE HOLE WAS USED TO PASS ANOTHER ANCHOR. IT WAS REPORTED THAT NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. : INVESTIGATION SUMMARY ==> ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE ANCHORS BREAK AND REMAIN INSIDE THE PATIENT, THE SUTURE HAD BURST AND DID NOT WORK. THE COMPLAINT DEVICE WAS IMPLANTED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [(B)(4)] NUMBER, AND NO NON-CONFORMANCES WERE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT THE ANCHORS BREAK AND REMAIN INSIDE THE PATIENT THE SUTURE HAS BURST AND DID NOT WORK. PRODUCT: 212044. LOT: 6L50324. PRODUCT: 212853. LOT: 6L18893.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126736 MINILOK QA+ # 2-0 OC V5 SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 212853 6L18893 10886705002429

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention