BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS SYSTEM CHANEY 13 TI PECTUS BAR

    MDR report key: 9532421 · Received December 30, 2019

    Report

    Report Number
    0001032347-2019-00589
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Date of Event
    November 29, 2019
    Report Date
    May 19, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036277185
    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 PRODUCTS REMAINING IMPLANTED. THE DHR WAS REVIEWED FOR PT-3341 AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT IN REGARDS TO THE BAR NOT BEING ABLE TO POSITIONED EASILY FOR PT-3341 LOT 953090. DUE TO LOW SALES OF THESE PARTS (PT-3339, PT-3340, PT-3341) A ONE-YEAR COMPLAINT REVIEW WAS CONDUCTED ON THE PART FAMILY (PT-XXXX) AND IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE). REGARDING FIT ISSUES, THERE IS A COMPLAINT RATE OF 0.16%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. 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 INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; 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: 0001032347-2019-00587, 0001032347-2019-00588, MEDICAL PRODUCTS: PECTUS SYSTEM CHANEY 13 TI PECTUS BAR, PART# PT-3339, LOT# 953070 PECTUS SYSTEM CHANEY 13 TI PECTUS BAR, PART# PT-3340, LOT# 953080 PECTUS SYSTEM CHANEY 13 TI PECTUS BAR, PART# PT-3341, LOT# 953090.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON COULD NOT OPTIMALLY POSITION STABILIZERS ON A PECTUS BAR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328396 PECTUS SYSTEM CHANEY 13 TI PECTUS BAR CUSTOM PECTUS BAR HRS BIOMET MICROFIXATION N/A 953090 00841036277185

    Patients

    Seq Age Sex Outcome Treatment
    1