BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 10179878 · Received June 22, 2020

    Report

    Report Number
    0001032347-2020-00274
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Report Date
    September 25, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    UDI-DI
    00841036011239
    PMA / PMN Number
    K972420
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS NON-VERIFIABLE. THE PECTUS TABLE TOP BENDER (ITEM# 01-3906, LOT# UNK) WAS NOT RETURNED FOR INVESTIGATION AND NO PHOTOS WERE PROVIDED. FOR THESE REASONS, NO FUNCTIONAL TESTING OR VISUAL INSPECTIONS COULD BE PERFORMED. THE DHR FOR THIS PRODUCT COULD NOT BE REVIEWED DUE TO THE LOT NUMBER REMAINING UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (01-3906) IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE TABLE TOP BENDER BEING STIFF, THERE IS A COMPLAINT RATE OF (B)(4), WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (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. DISTRIBUTOR ON BEHALF OF HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BENDER WAS STIFF, MAKING IT DIFFICULT TO BEND BARS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645489 PECTUS TABLE TOP BENDER BENDER HXW BIOMET MICROFIXATION N/A UNK 00841036011239

    Patients

    Seq Age Sex Outcome Treatment
    1