BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO QA+ #3/0 OC V4

    MDR report key: 10904469 · Received November 25, 2020

    Report

    Report Number
    1221934-2020-03583
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 5, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705002375
    PMA / PMN Number
    K080352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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: INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT WHEN THE DOCTOR PLACED THE ANCHOR IN THE PATIENT'S BONE, THE ANCHOR STAYED IN THE BONE AND THE SUTURE WAS CUT. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, A PHOTO WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTO, THE SUTURES WERE FOUND TO BE BROKEN AND FRAYED BY THE DISTAL ENDS. THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO AN EXCESSIVE FORCE APPLIED AT THE MOMENT WHEN THE SUTURE WAS HANDLED AND A SHARP INSTRUMENT COULD HAVE RUBBED THE SUTURE LEADING IN A BREAKAGE, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [6L60791] 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 · 0

    PRODUCT COMPLAINT # (B)(4). 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: 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. UDI: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A SURGICAL DELAY DID NOT OCCUR AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MINI QA ANCHOR. IT WAS ALSO REPORTED THE EVENT OCCURRED DURING A CMF SURGERY OF THE ATM AND THE DEVICE WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED BY THE HOSPITAL STAFF.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN CHILE THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT THE ANCHOR DEVICE STAYED IN THE BONE AND THE SUTURE WAS CUT WHEN IT WAS PLACED IN THE PATIENT'S BONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369230 MICRO QA+ #3/0 OC V4 SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 212843 6L60791 10886705002375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention