BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 7109481 · Received December 12, 2017

    Report

    Report Number
    0001032347-2017-00876
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Report Date
    May 9, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PK972420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE INSTRUMENT WAS VISUALLY EVALUATED AND FOUND TO BE IN POOR OVERALL CONDITION. THERE WERE SCRATCHES AND SIGNS OF WEAR ON THE INSTRUMENT; SIGNIFICANT DISCOLORATION WAS OBSERVED. THIS IS LIKELY FROM NORMAL WEAR AND TEAR AS THE INSTRUMENT WAS MANUFACTURED IN 2001. THE LEVER ARM FULLY ACTUATES WITH LITTLE NOTICEABLE FRICTION. THE INSTRUMENT WAS FUNCTIONALLY TESTED BY BENDING A TITANIUM PECTUS BAR, AND WAS SUCCESSFULLY ABLE TO BEND THE BAR WITH NO ISSUES. THE MANUFACTURING HISTORY WAS REVIEWED FOR THE POTENTIAL LOTS AND NO DISCREPANCIES WERE FOUND. THE COMPLAINT WAS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT: POTENTIAL LOTS ARE 021190 AND 042200. MANUFACTURING DATE: THE PART IS ETCHED WITH "AQ" MEANING IT WAS MANUFACTURED JANUARY - JUNE 2001. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UPON FOLLOW UP WITH THE FACILITY IT WAS REPORTED "THESE DID NOT DELAY A CASE OR CAUSE ANY PATIENT HARM - THE HOSPITAL HAD BEEN NOTICING FOR SOME TIME THAT THESE, THROUGH WEAR AND TEAR, WERE STRUGGLING TO BEND EFFICIENTLY."

    Description of Event or Problem · 1

    IT IS REPORTED THE PECTUS BENDER IS NOT BENDING BARS. THIS WAS NOT FOUND DURING SURGERY. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889868 PECTUS TABLE TOP BENDER PECTUS BAR BENDER HXW BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1