BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM CANNULATED DRILL

    MDR report key: 7428186 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02546
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 16, 2018
    Report Date
    March 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: 1419680, 6.5X80MM CANN CANC SCR 22, M12658A; 1419680, 6.5X80MM CANN CANC SCR 22, M13971A; 1419680, 6.5X80MM CANN CANC SCR 22, M13971A; 140129, GUIDE WIRE 3.2X230MM 3PK, NXY2K0Y; 140129, GUIDE WIRE 3.2X230MM 3PK, NXY2K0Y; 140129, GUIDE WIRE 3.2X230MM 3PK, NXY5003; 114629, COPE MB XLARGE -2 RESURF, ZB170601; 114629, COPE MB XLARGE -2 RESURF, ZB170801.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF RETURNED ITEM NOTED INSTRUMENT WAS SENT BACK IN SIX FRACTURED PIECES. SAME PART/LOT AND SIMILAR FAILURE WERE SENT FOR FURTHER ANALYSIS UNDER A DIFFERENT REPORTED COMPLAINT WHICH SEM ANALYSIS "SHOWED THAT IT FRACTURED DUE TO BENDING OVERLOAD. . THE SEM REPORT FROM PREVIOUS TESTING OF SAME ITEM/LOT OF INSTRUMENT NOTES THAT SEMI-QUANTITATIVE ELEMENTAL ANALYSIS USING ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (EDS ANALYSIS). HARDNESS TESTING INDICATED DEVICE WAS CONSISTENT WITH 455 STAINLESS STEEL, IN CONFORMANCE WITH SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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

    IT WAS REPORTED THAT A FRACTURED FEMORAL NECK PROCEDURE WAS PERFORMED WITH A CANNULATED DRILL. DURING THE PROCEDURE, THE TIP OF THE DRILL FRACTURED, AND MANY PIECES FELL INTO THE PATIENT'S BODY THE AFTER GUIDE PIN WAS INSERTED. ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (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.

    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, AND MANY PIECES FELL INTO THE PATIENT'S BODY THE AFTER GUIDE PIN WAS INSERTED. ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272573 5.0MM CANNULATED DRILL BIT, DRILL HTW ZIMMER BIOMET, INC. N/A ZB170601

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R