BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK MINILOK QUICHANCHOR PLUS W/ #2/0 ETHIBOND

    MDR report key: 1082284 · Received July 25, 2008

    Report

    Report Number
    1221934-2008-00362
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD IS HAD AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER OF THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT A MALE PT HAD HAND SURGERY SOMETIME IN EARLY 2007. TWO MITEK MINILOK QUICKANCHORS WERE USED FOR FINGER LIGAMENT FIXATION. ONE OF THE ANCHORS (CATALOGUE # 212851/LOT # 2935216) WAS USED ON THE LEFT MIDDLE FINGER, AND THE OTHER (SAME/LOT # 2911101) ON THE LEFT RING FINGER. THE PT PRESENTED WITH DRAINAGE AT THE "MIDDLE FINGER WOUND SITE". THE PT REPORTED THAT THE DRAINAGE HAD BEEN ONGOING FROM APPROX 1 MONTH AFTER THE REPAIR SURGERY TO THE PRESENT, 18 MOS. THE PT FURTHER INDICATED THAT HE HAD AT SOME POINT IN THE 18 MOS SEEN SOMEONE ELSE WITHOUT FURTHER ELABORATION (WE ASSUME THE SOMEONE ELSE WAS A MEDICAL DOCTOR). THE SURGEON PERFORMED A RE-SURGERY IN 2008. THE SURGEON NOTED THAT THERE WAS CONSIDERABLE PUSS SURROUNDING THE ANCHOR SITE AND THERE WAS NOTABLE OSTEOLYSIS AROUND THE ANCHOR. THE ANCHOR WAS REMOVED AND IS BEING SENT INTO MITEK. THE WOUND SITE WAS CULTURED, RESULTS NOT YET DEFINED. THE SURGEON EMPLOYED ANTIBIOTIC IRRIGATION TO THE WOUND SITE AND THE PT IS BEING TREATED WITH "KEFLEX" AS A MEANS OF ABATING ANY INFECTION. DEPENDING ON THE RESULTS OF THE CULTURE, THE SURGEON MAY DIRECT THE PT TO AN INFECTIOUS DISEASE SPECIALIST FOR DETERMINATION AND POSSIBLE FURTHER TREATMENT. NO PROGNOSIS BEYOND THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK MINILOK QUICHANCHOR PLUS W/ #2/0 ETHIBOND SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 212851 2935216

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention