BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED STRAIGHT DRIVER

    MDR report key: 13440597 · Received February 3, 2022

    Report

    Report Number
    0001822565-2022-00178
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 18, 2022
    Report Date
    May 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K103404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE HAS BEEN RECEIVED BY ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT VERIFIED ITEM AND LOT NUMBER. THE CANNULATED STRAIGHT DRIVER EXHIBITS SIGNS OF REPEATED USE (NICKED OR GOUGED) BUT IS NOT FRACTURED. PERFORMED DIMENSIONAL ANALYSIS ON CANNULATED STRAIGHT DRIVER LOT 60698536 REFERENCING NOTE#1 ON PRINT. IT'S CONFIRMED THE FUNCTIONAL GAGE ITEM# 25-1002-511-00 PASSES AND FUNCTIONS SMOOTHLY. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. NO PROBLEM FOUND FOR PART 00430707400; RETURNED PRODUCT FOUND TO BE CONFORMING TO SPECIFICATIONS. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. 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 CANNULATED STRAIGHT DRIVER WAS BROKEN DURING A PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749607 CANNULATED STRAIGHT DRIVER ORTHOPAEDIC PROSTHESIS IMPLANTATION INSTRUMENT, REUSABLE KWT ZIMMER BIOMET, INC. NI 60698536

    Patients

    Seq Age Sex Outcome Treatment
    1 Male