BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROFIX QA+#3/0 OC V-4

    MDR report key: 10425927 · Received August 19, 2020

    Report

    Report Number
    1221934-2020-02264
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 4, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705002481
    PMA / PMN Number
    K150209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THE STERILE LOAD INFORMATION WAS REVIEWED TO SEE IF THERE WERE ANY OTHER COMPLAINTS OF PATIENT INFECTION FOR ANY PRODUCTS STERILIZED IN THE SAME LOAD. THERE WERE 24 DIFFERENT LOTS OF PRODUCT CONTAINING 4864 DEVICES. A REVIEW OF THE COMPLAINT FILES REVEALED THAT THERE WERE TWO OTHER COMPLAINTS IN WHICH PATIENT INFECTION WAS REPORTED VIZ (B)(4), HOWEVER, THE LOT NUMBER INVOLVED IN THOSE TWO CASES WAS THE SAME AS REPORTED IN THIS COMPLAINT (5L95513). THE TWO OTHER CASES WERE ALSO REPORTED FROM THE SAME HOSPITAL. THE REVIEW OF THE COMPLAINT FILES REVEALED THERE WERE NO OTHER COMPLAINTS IN WHICH PATIENT INFECTION WAS REPORTED FOR A DIFFERENT LOT NUMBER IN THE SAME STERILE LOAD. THE ETO STERILIZATION OF THE DEVICE HAS BEEN DONE ACCORDING TO REQUIREMENTS OF ISO 11135:2014. THE CERTIFICATE OF STERILIZATION INDICATES THAT THE PHYSICAL ACCEPTANCE CRITERIA AND MICROBIOLOGICAL ACCEPTANCE CRITERIA WERE IN COMPLIANCE WITH THE VALIDATED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS ALSO PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (5L95513), AND NO NON-CONFORMANCE WAS IDENTIFIED. BASED OFF THE RESULTS FROM THE STERILE LOAD REVIEW, STERILIZATION CERTIFICATE AND MANUFACTURING RECORD EVALUATION, IT IS UNLIKELY THAT THE REPORTED PATIENT INFECTION WAS CAUSED BY THIS MITEK PRODUCT. ALTHOUGH IT IS UNLIKELY THAT THE MITEK PRODUCT WAS A SOURCE OF THE PATIENT¿S INFECTION, WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT. 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

    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. ADDITIONAL INFORMATION: B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. *WAS THIS PROCEDURE A REVISION SURGERY DUE TO AN ANCHOR PLACED IN AN EARLIER SURGERY BECAME LOOSE? YES. *HOW WAS THE LOOSE ANCHOR DISCOVERED (X-RAY)? YES, BUT HOSPITAL DID NOT OFFER TO US *ANY ADDITIONAL INFORMATION? NO.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFECTION POST-OP. IT WAS REPORTED THAT DURING THE SURGERY OF LATERAL COLLATERAL LIGAMENT REPAIR , NO ANY ABNORMAL SITUATION OCCURRED. AFTER SURGERY, FOUND THE INFECTION ISSUE. GIVEN THE REVISION OPERATION ON (B)(6) 2020, NOTED THE ANCHOR WAS LOOSE, REMOVED THE LOOSE ANCHOR, THE PATIENT IS STABLE AND LEFT FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892266 MICROFIX QA+#3/0 OC V-4 SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 212859 5L95513 10886705002481

    Patients

    Seq Age Sex Outcome Treatment
    1