BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS SYSTEM SHAFER 9.5 TI PECTUS BAR

    MDR report key: 9730202 · Received February 19, 2020

    Report

    Report Number
    0001032347-2020-00123
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 24, 2020
    Report Date
    July 22, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036279912
    PMA / PMN Number
    K061384
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT CANNOT BE VERIFIED. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED AND NO PHOTOGRAPHS BEING PROVIDED. THE DHR WAS REVIEWED THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. DUE TO THESE PRODUCTS BEING CUSTOM FIT A REVIEW WAS CONDUCTED ON ALL PART NUMBERS PT-XXXX FOR THE LAST YEAR REGARDING THE BAR NOT FITTING; (B)(4). THE MOST LIKELY UNDERLYING CAUSE CANNOT 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). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00122, 0001032347-2020-00123. MEDICAL PRODUCTS: PECTUS SYSTEM SHAFER 9 TI PECTUS BAR, PART# PT-3452, LOT# 964320. PECTUS SYSTEM SHAFER 9.5 TI PECTUS BAR, PART# PT-3453, LOT# 964310.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON PREFERRED THE CUSTOM PECTUS BAR TO BE SHORTER. THE CUSTOM PECTUS BARS WERE SUCCESSFULLY IMPLANTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188210 PECTUS SYSTEM SHAFER 9.5 TI PECTUS BAR PLATE, FIXATION, BONE HRS BIOMET MICROFIXATION N/A 964310 00841036279912

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR