BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILAGRO INTERFERENCE SCREW,12MM X 30MM

    MDR report key: 1963397 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00005
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS REPORTED TO US ON (B)(4) 2010; THIS IS NOW 68 DAYS AND BASED ON DUE DILIGENCE, WE ARE JUST TODAY MAKING THE DECISION TO FILE A REGULATORY REPORT. WE HAVE MADE MANY OUTREACHES OVER THE PAST 68 DAYS, THROUGH THE DILIGENT EFFORTS OF OUR AFFILIATE ACTING ON OUR BEHALF, TO THE REPORTING USER FACILITY ASKING THEM FOR FURTHER INFO, ANY TEST RESULTS AND GENERAL CLARITY IN AN EFFORT TO TRY AND DISCERN IF AND HOW THE REPORTED ADVERSE EVENT WAS CAUSED BY THE MITEK PRODUCT OR NOT AND IF A REGULATORY REPORT WAS IN ORDER. TO DATE THE REPORTING FACILITY HAS NOT, FOR WHATEVER REASON, RESPONDED TO OUR QUERIES. THE SURGEON/FACILITY STATE THAT THE PT HAD AN ALLERGIC REACTION TO 2 MITEK MILAGRO SCREWS, HOWEVER, IN THIS PROCEDURE OTHER DEVICES AND INSTRUMENTS FROM OTHER MANUFACTURERS WERE ALSO USED, INCLUDING WOUND CLOSURE SUTURES; WHERE THE INFECTION/REACTION SUPPOSEDLY IS. THE SURGEON/FACILITY HAVE NOT SUPPLIED US WITH TEST DATA AND REASON FOR THE ALLEGATION; THEY HAVE NOT SUPPLIED US WITH WHATEVER MEASURES WERE TAKEN TO REMEDY THE PT'S ISSUE; THEY HAVE NOT SUPPLIED US WITH THE PT'S STATUS OR PROGNOSIS; IN OTHER WORDS, THEY HAVE NOT COMMUNICATED ANYMORE THAN WAS ORIGINALLY REPORTED OR SUPPLIED US WITH ANY REASON. IN THE ORIGINAL COMPLAINT REPORT LOT NUMBERS WERE SUPPLIED AND A BATCH RECORD REVIEW FOR EACH LOT HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT BOTH BATCHES OF PRODUCT WERE PROCESSED WITHOUT INCIDENT AND, THEREFORE, THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE MITEK COMPLAINTS SYSTEM REVEALED NO OTHER SIMILAR COMPLAINTS OF ANY KIND FOR LOT 3305452 OF (B)(4) DEVICES, AND LOT 3344578 OF (B)(4) DEVICES THAT WERE RELEASED TO DISTRIBUTION. IN THE SAME STERILE LOAD FOR THESE COMPLAINT LOTS THERE WERE (B)(4) DEVICE/LOTS, A TOTAL OF (B)(4) DEVICES; THERE ARE NO OTHER SIMILAR COMPLAINTS FOR ANY OF THESE. BASED ON OUR INVESTIGATION AND DUE DILIGENCE, WE CANNOT DISCERN A ROOT OR UNDERLYING CAUSE FOR THE REPORTED ISSUE. THIS REPORT IS ONLY TO DOCUMENT A REPORTED ADVERSE EVENT, WHICH, MAY OR MAY NOT HAVE MERIT. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFO RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, 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

    OUR AFFILIATE IS REPORTING TO US THAT, AMONGST OTHER DEVICES, 2 MILAGRO SCREWS WERE USED TO FIXATE IN A KNEE REPAIR PROCEDURE. THE DOCTOR STATES THAT THE PT IS OR HAD AN ALLERGIC REACTION TO THE MILAGROS. ALSO USED IN THE PROCEDURE WERE SOME MENISCAL FASTENERS FROM ANOTHER MANUFACTURE. FURTHER TO THIS, THE PT DEVELOPED AN INFECTION TO THE WOUND CLOSURE SUTURES, NOT A MITEK PRODUCT. THIS IS ALL OF THE INFO THAT HAS BEEN MADE AVAILABLE TO MITEK; QUESTIONS OUT FOR FURTHER DETAIL. ALSO SEE ASSOCIATED MDR 1221934-2011-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILAGRO INTERFERENCE SCREW,12MM X 30MM SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 231860 3344578

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention