BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE MARXMEN STRAIGHT STRAIGHT

    MDR report key: 6970198 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09340
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 1, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDR
    PMA / PMN Number
    PK061776
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: CATALOG NUMBER: 900320, LOT NUMBER: 082290. CATALOG NUMBER: 900320, LOT NUMBER: 845670. CATALOG NUMBER: 900321, LOT NUMBER: UNKNOWN. FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO HOSPITAL DISCARDING IT AS BIOHAZARD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09339, 0001825034-2017-09341.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY, THE ANCHOR OF THIS DEVICE DID NOT DEPLOY. TWO OTHER PRODUCTS EXPERIENCED THE SAME MALFUNCTION DURING THIS SURGERY. THE SURGEON USED A DIFFERENT TYPE OF DEVICE TO COMPLETE THE SURGERY. NO PATIENT HARM OR SIGNIFICANT DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749567 MAXFIRE MARXMEN STRAIGHT STRAIGHT STAPLE, FIXATION JDR ZIMMER BIOMET, INC. N/A 232850

    Patients

    Seq Age Sex Outcome Treatment
    1