BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSALOK ANCHOR WITH THREADER TAB

    MDR report key: 8962602 · Received September 4, 2019

    Report

    Report Number
    1221934-2019-58188
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 7, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705001163
    PMA / PMN Number
    K063478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRO-CODES: GAM; GAS; GAT; MBI; NEW. A REVIEW OF THE DEVICE HISTORY RECORD: DEVICE HISTORY LOT NO NON-CONFORMANCE'S WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 8/12/2019. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW NULL. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. NO NON-CONFORMANCE'S WERE IDENTIFIED FOR THIS PART NUMBER, LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 8/12/2019. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES MITEK REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2019. WHEN THE SURGEON WAS THREADING THE SUTURE TO THE ANCHOR (210800), THE WIRE BROKE. THE PROCEDURE WAS COMPLETED LESS THAN A 30-MINUTE DELAY. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756044 VERSALOK ANCHOR WITH THREADER TAB SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 3L39782 10886705001163

    Patients

    Seq Age Sex Outcome Treatment
    1