BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFIXUS HFN 130 DEG 11MM X 180MM

    MDR report key: 7804719 · Received August 22, 2018

    Report

    Report Number
    0001825034-2018-04698
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    June 23, 2018
    Report Date
    January 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    ZFA 2018-00344
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. A FIELD ACTION WAS CONDUCTED IN WHICH ZIMMER VOLUNTARILY REMOVED THE REPORTED PRODUCT FROM THE FIELD DUE TO A HIGHER THAN ANTICIPATED COMPLAINT RATE FOR THE REPORTED FAILURE. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: HFN 130 DEG 11MM X180MM, CAT#: 814511180 LOT#: 944660; HFN 130 DEG 13MM X180MM, CAT#: 814513180 LOT#: 970530. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ALL ASSOCIATED REPORTS: 0001825034-2018-04697, 0001825034-2018-04698, 0001825034-2018-04699. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [RETAINED BY HOSPITAL] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF A HIP FRACTURE NAIL, THE SET SCREW WOULD NOT FUNCTION PROPERLY AND WAS JAMMED, CAUSING THE NEED TO REMOVE THE NAIL FROM THE PATIENT. TWO (2) ADDITIONAL NAILS WERE TESTED, AND ALSO HAD JAMMED SET SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FOURTH (4) NAIL, HOWEVER THERE WAS A GREATER THAN THIRTY (30) MINUTE DELAY TO THE PROCEDURE AND THE PATIENT'S FEMUR REQUIRED FURTHER REAMING FOR A LARGER SIZE NAIL. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645569 AFFIXUS HFN 130 DEG 11MM X 180MM ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A 901360

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R