BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCH NAIL LONG 11MM RT 38CM M

    MDR report key: 12797121 · Received November 11, 2021

    Report

    Report Number
    0001825034-2021-03111
    Event Type
    Injury
    Date Received
    November 11, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00880304488076
    PMA / PMN Number
    K050118
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 29260 LAG SCREW ASSY SOLID FIXED 105MM 874620. 14-405032 TI-DBLE LEAD CORT 5.0X32MM SCREW 324980. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE PATIENT UNDERWENT SURGERY TO REPAIR MULTIPLE HIP FRACTURES. TWO YEARS POST IMPLANTATION, THE PATIENT'S DAUGHTER HAS REPORTED THAT THE FIXATION NAIL HAS BROKEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691552 TROCH NAIL LONG 11MM RT 38CM M ROD, FIXATION HSB ZIMMER BIOMET, INC. N/A 678400 00880304488076

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other