BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LORENZ PECTUS SUPPORT BAR SYSTEM

    MDR report key: 10362355 · Received August 4, 2020

    Report

    Report Number
    0001032347-2020-00343
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00888233027694
    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 IS NON-VERIFIABLE. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION BECAUSE IT WAS IMPLANTED WITHOUT IMPACT TO THE PROCEDURE. NO PHOTOS, SCANS, X-RAYS, OR PHYSICIAN'S REPORTS WERE PROVIDED. FOR THESE REASONS, NO VISUAL EVALUATIONS OR FUNCTIONAL TESTING COULD BE CONDUCTED. THE DHR WAS REVIEWED AND NO NON-CONFORMANCE WAS FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR ALL PATIENT MATCHED PECTUS BARS (ITEM# PT-XXXX & PS-XXXX) IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE BARS BEING TOO LONG, THERE IS A COMPLAINT RATE OF(B)(6) WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE COULD NOT BE DETERMINED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. 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 WAS 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: 0001032347-2020-00342, 0001032347-2020-00343. MEDICAL PRODUCTS: LORENZ PECTUS SUPPORT BAR SYSTEM, PART# PT-3697, LOT# 991830. LORENZ PECTUS SUPPORT BAR SYSTEM, PART# PT-3698, LOT# 991840.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOM PECTUS BARS WERE NOT AN IDEAL FIT DURING IMPLANTATION. THE SURGEON REPORTED THE LOWER BAR WAS TOO LONG. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829272 LORENZ PECTUS SUPPORT BAR SYSTEM CUSTOM MADE DEVICE HRS BIOMET MICROFIXATION N/A 981840 00888233027694

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR