BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM ACORN REAMER

    MDR report key: 2002382 · Received January 28, 2011

    Report

    Report Number
    1221934-2011-00034
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HWQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION; COMPLAINT DEVICES DISCARDED AT USER FACILITY. NO LOT NUMBER HAS BEEN SUPPLIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. WE CANNOT TELL ANYTHING FROM THIS; CANNOT DISCERN THE UNDERLYING REASON FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE, THE SURGEON OBSERVED METAL SHAVINGS FALLING INTO THE PATIENT'S BODY WITH THE USE OF TWO REAMERS; A 6MM ACORN REAMER AND A 6MM FLUTED REAMER. ALL OF THE DEBRIS WAS REMOVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICES DISCARDED AT USER FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2011-00035.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6MM ACORN REAMER ARTHROSCOPIC INSTRUMENT HWQ DEPUY MITEK 219336 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK