BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM CANNULATED DRILL

    MDR report key: 7428187 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02549
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 16, 2018
    Report Date
    February 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. TESTING WAS PERFORMED ON RETURNED DEVICE INCLUDING SCANNING ELECTRON MICROSCOPY (SEM ANALYSIS). THIS "SHOWED THAT IT FRACTURED DUE TO BENDING OVERLOAD." QUASI-CLEAVAGE MODE FRACTURE ARTIFACTS ARE NOTED THROUGHOUT THE FRACTURE SURFACE. THE FRACTURE SURFACE SHOWS MULTIPLE EXIT SITES NEAR THE INNER DIAMETER OF THE DRILL BIT, INDICATING THE CRACKS INITIATED NEAR THE OUTER DIAMETER OF THE DEVICE AND PROPAGATED IN THROUGH ITS INNER DIAMETER. MATERIAL SPECIFICATIONS WERE FOUND TO BE CONFORMING TO DEVICE SPECIFICATIONS. HARDNESS TESTING WAS PERFORMED ON THE FRACTURED DRILL BIT, AND IT WAS ALSO FOUND TO BE IN CONFORMANCE WITH SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) NOTED NO DEVIATIONS OR ANOMALIES RELATED TO THE REPORTED EVENT. REVIEW OF X-RAYS PROVIDED NOTED 2 SEPARATE METALLIC FOREIGN BODIES WITHIN THE LATERAL ASPECT OF THE INTERTROCHANTERIC REGION OF THE LEFT HIP. 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) (B)(6). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 1419670, 6.5X70MM CANN CANC SCR 22, M04237F, 14097, 9.5MM CONNECTOR (150MM), CA58M50, 14191, 8MM FLAT WASHER 3PK, AA4NH4, 1419275, 8.0X75MM CANN CANC SCR 24 NS, DFHCDN, 140129, GUIDE WIRE 3.2X230MM 3PK, NXZ331A, 140129, GUIDE WIRE 3.2X230MM 3PK, NXZ331A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OPERATION WAS PERFORMED WITH A CANNULATED DRILL. DURING THE PROCEDURE, THE TIP OF THE DRILL FRACTURED INTO SEVERAL PIECES, AND THREE PIECES REMAINED IN SITU. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272574 5.0MM CANNULATED DRILL BIT, DRILL HTW ZIMMER BIOMET, INC. N/A ZB170601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention