BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 HEALIX PEEK ANCH.W/OCORD

    MDR report key: 8290746 · Received January 30, 2019

    Report

    Report Number
    1221934-2019-56281
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    April 12, 2016
    Report Date
    July 23, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705007530
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THREE ANCHORS WERE RECEIVED FOR THIS COMPLAINT WITH NO LOT IDENTIFICATION. VISUAL OBSERVATION FOR ALL THREE DEVICES CONFIRMS THE DISTAL TIPS OF THE ANCHORS ARE BROKEN. THE BROKEN DISTAL ENDS FOR TWO OUT OF THE THREE ANCHORS ARE HELD IN PLACE BY SUTURE, THE THIRD ANCHORS DIDN¿T HAVE THE SUTURE. ALL THREE ANCHORS HAD STAINS AND TISSUE DEBRIS; INDICATING THAT THE FAILURE OCCURRED DURING INSERTION. WHEN OBSERVED UNDER MAGNIFICATION, NO STRUCTURAL ANOMALIES WERE OBSERVED THAT COULD HAVE CONTRIBUTED TO THIS FAILURE. ANCHOR BREAKAGES ARE TYPICALLY ASSOCIATED WITH OFF AXIS INSERTION, LEVERING DURING INSERTION, HARD BONE QUALITY OR USING INCORRECT INSTRUMENTATION FOR PREPARING BONE HOLE. P/N: 222205; LOT: 3733058. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, 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. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF NEOPLASTY IT WAS NOTED THREE SCREWS WERE BROKEN. THE BROKEN PIECE DIDN'T FALL INTO PATIENT. CHANGED THE NEW REPLACEMENTS TO COMPLETE. THERE WAS NO ADVERSE EVENT OR EXTENDED SURGERY. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84199 4.5 HEALIX PEEK ANCH.W/OCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 10886705007530

    Patients

    Seq Age Sex Outcome Treatment
    1