BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO QA+ #3/0 ETH V-4

    MDR report key: 8170524 · Received December 17, 2018

    Report

    Report Number
    1221934-2018-55691
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    January 1, 2018
    Report Date
    December 10, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705002528
    PMA / PMN Number
    K024115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART (212865), LOT (L964344) COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT, WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED, AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY 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.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING SL BAND REFIXATION SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO MICRO QUICK ANCHOR+ 3/0 ETHIBOND DEVICES WERE NOT POSSIBLE TO RELEASE FROM THEIR MECHANSMS. ACCORDING TO THE REPORTER, THE DEVICES WERE NOT INSIDE THE PATIENT, SO NO REMOVAL WAS NECESSARY. IT WAS FURTHER REPORTED THAT THERE WAS NO BONE HOLE NEEDED AT THE TIME OF THE EVENT. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE BUT IT WAS REPORTED THAT SPARE DEVICES WERE AVAILABLE FOR USE TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011427 MICRO QA+ #3/0 ETH V-4 SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US L964344 10886705002528

    Patients

    Seq Age Sex Outcome Treatment
    1