BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI QA+ #0 ETH OS-2 *EA

    MDR report key: 7499845 · Received May 9, 2018

    Report

    Report Number
    1221934-2018-50608
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    February 7, 2018
    Report Date
    May 9, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705001972
    PMA / PMN Number
    K992487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). MISSED TO ENTER 510(K) NUMBER K992487 IN THE INITIAL MEDWATCH. HENCE SUBMITTING FOLLOW-UP MEDWATCH TO UPDATE THE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATION REVEALS THAT THE ANCHOR POSITIONED AT THE TIP OF THE INSERTER IS NOT ALIGNED/BENT TO THE INSERTER SHAFT. THERE WERE STAINS NEAR THE INSERTED DISTAL END AND EVEN THE SUTURE IS DISCOLORED NEAR THE ANCHOR CONFIRMING THAT THIS IS NOT AN OUT OF THE BOX FAILURE AND THE DEVICE HAS BEEN USED. SO, THE REPORTED FAILURE CANNOT BE CONFIRMED. TO INVESTIGATE FURTHER, THE ANCHOR WAS REMOVED FROM THE TIP AND IT WAS NOTICED THAT THE INSERTER TIP WAS BENT WHICH CAUSED THE ANCHOR TO LOOK BENT. INSERTER TIP BENT MIGHT BE CAUSED DUE TO OFF-AXIS INSERTION, LEVERING DURING INSERTION OR HARD BONE QUALITY. A DHR REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, 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: (B)(4).

    Description of Event or Problem · 1

    ANCHOR TIP BEND. IT WAS NOTED THAT TIP OF ANCHOR BENT WHEN OUT OF PACKAGE. CHANGED THE NEW ONE TO COMPLETE. THERE WAS NO ADVERSE EVENT ON PATIENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340540 MINI QA+ #0 ETH OS-2 *EA SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US L553148 10886705001972

    Patients

    Seq Age Sex Outcome Treatment
    1