BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STN PN THD TIP .125X2.5IN 2PK

    MDR report key: 9315104 · Received November 13, 2019

    Report

    Report Number
    0001825034-2019-05138
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 16, 2019
    Report Date
    May 1, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED ONE VNGD SHORTQUICK-RELEASE DRILL WITH A FRACTURED PIECE OF A STN PN THD TIP .125X2.5IN 2PK LODGED WITHIN THE SHAFT. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A DEFINITIVE 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 PRODUCTS: 32-486259, VNGD SHORTQUICK-RELEASE DRILL, LOT # 180402. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TKA, THE THREADED STEINMAN PIN BROKE INSIDE THE PINDRIVER WHEN ENTERED INTO THE GUIDE BLOCK. THERE WAS NO IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110755 STN PN THD TIP .125X2.5IN 2PK INSTRUMENT, KNEE LXH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1