BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT CANN AO 2.0X65MM NS

    MDR report key: 7804813 · Received August 22, 2018

    Report

    Report Number
    0001825034-2018-04792
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    June 25, 2018
    Report Date
    October 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PK142658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS : HDLS CMPN SCR 3.0X16 NS, CAT#: 110018451 LOT#: NI. HDLS CMPN SCR 3.0X20 NS, CAT#: 110018453 LOT#: NI. HDLS CMPN SCR 3.0X26 NS, CAT#: 110018456 LOT#: NI. K-WIRE 0.9X70MM NS, CAT#: 110018526 LOT#: NI. T7 DRIVER CANN AO, CAT#: 110018531 LOT#: NI. 3.0 HEAD RELIEF DRILL AO NS, CAT#: 110027747 LOT#: NI (QTY 2). K-WIRE 0.9X70MM NS, CAT#: 110018526 LOT#: NI. INVESTIGATION OF THE INCIDENT IS CURRENTLY ONGOING A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [HOSPITAL DISCARDED] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BUNIONECTOMY, THE DRILL TIP FRACTURED INTO MULTIPLE PIECES IN THE PATIENT'S RIGHT TOE AND SOME FRAGMENTS REMAIN IN SITU. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. 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
    647301 DRILL BIT CANN AO 2.0X65MM NS SCREW, FIXATION HWC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S