BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSALOK THREADER TAB *EA

    MDR report key: 9101038 · Received September 20, 2019

    Report

    Report Number
    1221934-2019-58425
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    August 21, 2019
    Report Date
    August 23, 2019
    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

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: 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, 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. FURTHER, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. 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. UDI:UNAVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2019. AFTER THE ANCHOR (210800) WAS FIXED, IT BACKED OUT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION COULD NOT BE PROVIDED BY THE AFFILIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892263 VERSALOK THREADER TAB *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1