BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 7037033 · Received November 16, 2017

    Report

    Report Number
    0001032347-2017-00807
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 17, 2017
    Report Date
    March 29, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PK972420
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCT IDENTITY HAS BEEN CONFIRMED. THE DEVICE WAS RETURNED WITH NO PACKAGING. THE COMPLAINT IS THAT THE BENDER IS GETTING HARDER TO USE. BASED ON A VISUAL INSPECTION OF THE DEVICE, IT IS IN OVERALL GOOD COSMETIC CONDITION. THE DEVICE WAS FUNCTIONALLY TESTED BY BENDING A 17" LORENZ PECTUS SUPPORT BAR. IT WAS FOUND THAT THE DEVICE COULD EASILY BEND THE BAR AND THE HANDLE WAS NOT HARD TO MOVE; THEREFORE THE COMPLAINT IS UNCONFIRMED. DEVICE ANALYSIS INDICATED THAT THE DEVICE MET SPECIFICATION. THE MANUFACTURING HISTORY WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF A MANUFACTURING DEFECT. 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

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT IS REPORTED THE BENDER IS "GETTING HARDER TO USE". THERE WAS NO PATIENT INJURY AND A DELAY OF ONE MINUTE. THE PROCEDURE WAS COMPLETED WITH THE SAME TABLE TOP BENDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818159 PECTUS TABLE TOP BENDER PECTUS BENDER HXW BIOMET MICROFIXATION N/A 103114E14

    Patients

    Seq Age Sex Outcome Treatment
    1