BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE KNTLSS PK

    MDR report key: 10319982 · Received July 24, 2020

    Report

    Report Number
    1221934-2020-01903
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Report Date
    July 9, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MBI
    UDI-DI
    10886705023486
    PMA / PMN Number
    K130539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: CORRECTION: G1-2: THE MANUFACTURING LOCATION HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. ADDITIONAL INFORMATION: 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 (L991807), 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

    UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLSS PK DEVICE BECAME STUCK IN THE INSERTER AFTER IMPLANTING FOR A LATERAL ROW. SUBSEQUENTLY, THE ANCHOR CAME OUT WHILE ATTEMPTING TO PULL THE INSERTER OUT. THERE WAS A SURGICAL DELAY OF TWO MINUTES TO COMPLETE THE SURGERY WITH ANOTHER LIKE DEVICE. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786336 5.5 HEALIX ADVANCE KNTLSS PK SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI DEPUY MITEK LLC US 222334 L991807 10886705023486

    Patients

    Seq Age Sex Outcome Treatment
    1