BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK FASTIN NON ABSORBABLE ANCHOR IMPLANT

    MDR report key: 5034417 · Received August 27, 2015

    Report

    Report Number
    1221934-2015-00943
    Event Type
    Injury
    Date Received
    August 27, 2015
    Report Date
    August 7, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK MEDICAL AFFAIRS DEPARTMENT DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAINS RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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 COMPLAINT WAS FORWARDED TO MITEK COMPLAINTS BY OUR MEDICAL AFFAIRS TEAM WHO REVIEWED A JOURNAL ARTICLE WHERE MITEK FASTIN RC ANCHORS WERE USED FOR A ROTATOR CUFF REPAIR. THE PATIENT WAS A 69 YEAR OLD WOMAN WHO BRUISED HER RIGHT SHOULDER IN A FALL. MAGNETIC RESONANCE IMAGING SHOWED A MASSIVE TEAR OF THE ROTATOR CUFF. BECAUSE OF THE DIFFICULTY OF REATTACHING THE RETRACTED TENDONS, A PARTIAL SINGLE-ROW REPAIR OF BOTH THE INFRASPINATUS AND SUBSCAPULARIS TEARS USING 2 FASTIN ANCHORS WAS PERFORMED. SIX MONTHS AFTER THE SURGERY, RAPID PROGRESSION OF THE DEFORMITY OF THE HUMERAL HEAD WAS APPARENT. TWO MONTHS LATER SINCE THE SURFACE OF THE HUMERAL HEAD WAS COLLAPSED, THE PATIENT RECEIVED A HUMERAL HEAD REPLACEMENT. (B)(4). KNEE SURG SPORTS TRAUMATOL ARTHROSC (2015) 23:514-516. DOI 10:1007/S00167-013-2790-7. RAPID COLLAPSE OF THE HUMERAL HEAD AFTER ARTHROSCOPIC ROTATOR CUFF REPAIR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567308 MITEK FASTIN NON ABSORBABLE ANCHOR IMPLANT ANCHOR IMPLANTS JDR DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R