BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7MM BONE DOWEL COLLET

    MDR report key: 7925705 · Received October 2, 2018

    Report

    Report Number
    0001825034-2018-09321
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 3, 2018
    Report Date
    February 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWK
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE FRACTURED PIECE NAMED SLIDER IN THE PHOTOS IS FROM THE BODY OF THE SLIDER. IT APPEARS THAT A DOWEL PIN HAS SHEARED INSIDE THE BODY THAT HOLDS THE SHANK IN PLACE AND ALLOWED THE SHANK TO MOVE INSIDE OF THE SLIDER ALLOWING THE BEARINGS TO POP OUT OF THE COLLAR AND FRACTURE. THE DOWEL PINS LOCK THE SHANK FROM ROTATING AND THE RETURNED INSTRUMENT DOES ROTATE SLIGHTLY. THE FRACTURED SLIDER IS MISSING A SMALL PIECE THAT WAS NOT RETURNED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). FDA PRODUCT CODE: HWK. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT FRACTURED DURING USE. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768258 7MM BONE DOWEL COLLET TRAUMA, INSTRUMENT HWK ZIMMER BIOMET, INC. 039890

    Patients

    Seq Age Sex Outcome Treatment
    1