BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG PARTIAL THREAD 2.5X14MM

    MDR report key: 10568247 · Received September 22, 2020

    Report

    Report Number
    0001825034-2020-03548
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    July 22, 2020
    Report Date
    October 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    NI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. INSUFFICIENT INFORMATION PROVIDED. UNABLE TO PERFORM A COMPATIBILITY CHECK. MEDICAL RECORDS WERE NOT PROVIDED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03192, 0001825034-2020-03549. CONCOMITANT MEDICAL PRODUCTS: PEG DRIVER FAST 2.0MM PART# FPD20 LOT# UNK. PEG PARTIAL THREAD 2.5X16MM PART# TP16000 LOT# UNK. REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED APPROXIMATELY TWO (2) MONTHS AGO, PATIENT UNDERWENT A REVISION TO REMOVE DVR PLATES AS STANDARD REMOVAL PROTOCOL. SURGEON WAS UNABLE TO REMOVE THE SCREWS DUE TO THE SCREWDRIVER TIP COLLAPSING AND THE SCREW HEADS BEING MILLED. THE IMPLANT REMAINED IN THE PATIENT AND THE PROCEDURE WAS ABORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032299 PEG PARTIAL THREAD 2.5X14MM PROSTHESIS, TRAUMA HWC ZIMMER BIOMET, INC. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R