BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL 1.6X50MM 22MM STOP

    MDR report key: 5831667 · Received July 28, 2016

    Report

    Report Number
    0001032347-2016-00363
    Event Type
    Injury
    Date Received
    July 28, 2016
    Report Date
    June 30, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    PK062842
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 1032347-2016-00362.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, A PRODUCT EVALUATION WAS CONDUCTED. ACCORDING TO THE EVALUATION, THE PRODUCT IDENTITY WAS NOT CONFIRMED AS A RESULT OF THE PART NOT BEING RETURNED. THE DISTRIBUTOR PROVIDED PICTURES WHICH WERE EXAMINED IN THE EVALUATION. UPON EXAMINATION, THE PICTURES CLEARLY SHOW THAT ONE DRILL IS BENT AND ONE DRILL IS FRACTURED TRANSVERSELY. THEREFORE, THE COMPLAINT IS CONFIRMED. DISTRIBUTOR STATES THE CUSTOMER TRIED TO USE THE DRILL BIT WITH ANOTHER MANUFACTURER'S PRODUCT. IT IS UNCLEAR IF THIS CONTRIBUTED TO THE FRACTURE. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT RETURNED. THE CERTIFICATIONS FOR THESE PRODUCTS HAVE BEEN REVIEWED AND NO NON-CONFORMANCE WAS FOUND FOR THIS PRODUCT. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. REPORT 1 OF 2 IS REPORTED ON MFR #1032347-2016-00362-1.

    Description of Event or Problem · 1

    IT IS REPORTED THE DRILL BIT WAS LOADED INTO SURGAIRITOME (NOT MANUFACTURED BY ZIMMER BIOMET) AND BROKE WHEN IT TOUCHED THE PATIENT. A SECOND DRILL BIT WAS USED AND IT BROKE. THE SALES ASSOCIATE STATED IT LOOKS LIKE THE FLUTE OF THE DRILL BIT DOESN'T COME PAST THE CAP OF THE SURGARITOME AND IT BROKE RIGHT WHERE THE DRILL EXITS THE CAP. NOTHING WAS RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481623 DRILL 1.6X50MM 22MM STOP DRILL HBE BIOMET MICROFIXATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention