BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES CAPTURED DO NOT IMPLANT

    MDR report key: 9753777 · Received February 26, 2020

    Report

    Report Number
    0001825034-2020-00868
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    January 27, 2020
    Report Date
    July 29, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATE/CORRECTED UPDATED: B4, B5, D4, D10, G4, G7, H2, H3, H6 VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS ONE OF THE HOLES OF THE GUIDE WAS WORN AND DAMAGED, WHICH WAS PROBABLY CAUSED WHEN THE DRILL WAS JAMMED. A FUNCTIONAL TEST WAS PERFORMED ON THE GUIDE AND HOLES IN THE CUT GUIDE WERE CHECKED WITH METRIC PINS FROM GAGE SET 25-2003-858-00-A. ONE OF THE HOLES WOULD NOT ACCEPT MINIMUM PIN THRU, WHICH WAS DUE TO THE DAMAGE IN THE HOLE SEEN CAUSED DURING USAGE OF DEVICE. PHOTOGRAPHS WERE PROVIDED THAT SHOWED THE PIN STUCK IN THE CUT GUIDE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DEVIATION OR ANOMALIES DURING MANUFACTURING. THE DRILL PIN WAS COMPATIBLE TO BE USED WITH THE GUIDE. A 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). 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. CONCOMITANT MEDICAL PRODUCT: 00590102000, HEADLESS TROCAR DRILL PIN, LOT # 64521559. EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TKA, THE OBLIQUE PIN BECAME JAMMED IN THE GUIDE AND WAS UNABLE TO BE REMOVED. ANOTHER PIN AND GUIDE WERE USED WITH NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216306 TIBIAL CUT GUIDE RIGHT MEDIAL 5 DEGREES CAPTURED DO NOT IMPLANT INSTRUMENT, SURGICAL, ORTHOPEDIC HTJ ZIMMER BIOMET, INC. N/A 64268691

    Patients

    Seq Age Sex Outcome Treatment
    1