BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 9953974 · Received April 13, 2020

    Report

    Report Number
    0001032347-2020-00219
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    March 26, 2020
    Report Date
    September 21, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION SHOWS VERY HEAVY WEAR. THE SCREW FOR THE BENDER WITH THE UNK LOT WAS RECEIVED DISASSEMBLED. WHEN ATTEMPT WAS MADE TO REASSEMBLE THE RAM ASSEMBLY THE THREADED PORTION OF THE SCREW WOULD NOT THREAD ONTO THE BENDER. THERE IS DAMAGE TO THE THREADS AND AS A RESULT THE ASSEMBLY CANNOT BE REASSEMBLED. THERE WILL BE NO DHR REVIEW AS THE LOT NUMBER REMAINS UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART 01-3906 AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE SCREW BECOMING CROSS THREADED, THERE IS A COMPLAINT RATE OF 2.56%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE IS GENERAL WEAR AND TEAR FROM MANY USES AND WELL AS DAMAGE TO THE THREADS. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00218, 0001032347-2020-00219. MEDICAL PRODUCTS: PECTUS TABLE TOP BENDER, PART# 01-3906, LOT# TB07, PECTUS TABLE TOP BENDER, PART# 01-3906, LOT# TB02 E4 - THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE - (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE TABLE TOP BENDER WAS HARD TO MOVE DURING A PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415888 PECTUS TABLE TOP BENDER BENDER HXW BIOMET MICROFIXATION N/A UNKNOWN 00841036011239

    Patients

    Seq Age Sex Outcome Treatment
    1