BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SHORT 5-HOLE DRILL GUIDE LARGE

    MDR report key: 6734299 · Received July 21, 2017

    Report

    Report Number
    0001825034-2017-04995
    Event Type
    Injury
    Date Received
    July 21, 2017
    Date of Event
    June 20, 2017
    Report Date
    April 19, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CMP(B)(4). MEDICAL PRODUCT: CATALOG #: 32-472711, GUIDE 5 HOLE, LOT # 910880. CATALOG #: 178554, CPS SHORT ANCHOR PLUG 12MM, LOT # 876770. CATALOG #: RD425008, COMPRESS CROSS BAR ASSY, LOT # 879190. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04993. PRODUCT EXPECTED, NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL GUIDES USED DURING SURGERY WERE DAMAGED. THEY DID NOT TIGHTEN TO THE DEVICE THAT ALIGNS THE DRILL HOLES FOR THE ANCHOR PLUG. ONE KNOB WAS BENT AND THE OTHER WAS THE WRONG KNOB. THE ANCHOR WAS THROWN AWAY AND THE DRILL GUIDE WAS CEMENTED IN PLACE. THE TRAY WAS DAMAGED WHICH REQUIRED A REPLACEMENT. AS A RESULT OF THE EVENT, AN HOUR DELAY OCCURRED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513949 COMPRESS SHORT 5-HOLE DRILL GUIDE LARGE PROSTHESIS, KNEE FZX BIOMET ORTHOPEDICS 730810

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention SEE H10 NARRATIVE