BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSALOK THREADER TAB *EA

    MDR report key: 11727356 · Received April 26, 2021

    Report

    Report Number
    1221934-2021-01324
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    PMA / PMN Number
    K063478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 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 (6L94421), 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. DEVICE HISTORY LOT: AN MRE REVIEW WAS PERFORMED AND RESULTS OBTAINED AS BELOW: PRODUCT CODE: 210800. LOT NUMBER: 6L94421. ANOMALIES OR DISCREPANCIES (NON-CONFORMANCE): NONE.

    Additional Manufacturer Narrative · 1

    UDI: (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 (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR DEVICE HAD COME OFF. ACCORDING TO THE REPORT, THE PATIENT WAS X-RAYED AFTER THE PROCEDURE; AND IT WAS FOUND THEN. THE SURGEON REMOVED THE ANCHOR AND USED A REPLACEMENT TO COMPLETE THE PROCEDURE WHICH RESULTED IN AN HOUR SURGICAL DELAY. NO PRODUCT DEFECTIVENESS WAS RECOGNIZED AS THE SURGEON ADMITTED THAT THE ANCHOR WAS NOT INSERTED VERTICALLY AGAINST THE BONE. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621506 VERSALOK THREADER TAB *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 6L94421

    Patients

    Seq Age Sex Outcome Treatment
    1