BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFIXUS HFN 130 DEG 11MM X 180MM

    MDR report key: 7777965 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-04611
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 19, 2018
    Report Date
    October 24, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ALL THREE NAILS WERE RETURNED AND EVALUATED. THE EVENT OF JAMMED SET SCREWS WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND ROOT CAUSE WAS UNABLE TO BE DETERMINED. CORRECTIVE ACTION HAS BEEN INITIATED TO FURTHER ADDRESS THE EVENT A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    IT WAS REPORTED THAT DURING A HIP FRACTURE NAILING PROCEDURE, WHILE THE OPERATING SURGEON WAS ATTEMPTING TO IMPLANT THE LAG SCREW, THE SET SCREW WAS UNABLE TO ADVANCE. THE SURGEON THEN HAD TO REMOVE EVERYTHING AND WAS STILL UNABLE TO MOVE THE SET SCREW. TWO (2) MORE NAILS WERE OPENED AND TESTED, AND THESE SET SCREWS ALSO WOULD NOT ADVANCE. THE SURGERY WAS LATER SUCCESSFULLY COMPLETED WITH A NEW NAIL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS- HFN 130 DEG 11MM X 180MM CATALOG#: 814511180 LOT#: 944660, HFN 130 DEG 11MM X 180MM CATALOG#: 814511180 LOT#: 901380. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2018-04612, 0001825034-2018-04614.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP FRACTURE NAILING PROCEDURE, WHILE THE OPERATING SURGEON WAS ATTEMPTING TO IMPLANT THE LAG SCREW, THE SET SCREW WAS UNABLE TO ADVANCE. THE SURGEON THEN HAD TO REMOVE EVERYTHING AND WAS STILL UNABLE TO MOVE THE SET SCREW. TWO (2) MORE NAILS WERE OPENED AND TESTED, AND THESE SET SCREWS ALSO WOULD NOT ADVANCE. THE SURGERY WAS LATER SUCCESSFULLY COMPLETED WITH A NEW NAIL. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619606 AFFIXUS HFN 130 DEG 11MM X 180MM ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A 901300

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention