BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANKLE LOCKING NAIL 11 X 150MM

    MDR report key: 13535858 · Received February 15, 2022

    Report

    Report Number
    0001825034-2022-00336
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 20, 2022
    Report Date
    June 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00887868093593
    PMA / PMN Number
    K081243
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G1-2; G3; G6; H1; H6 H6: COMPONENT CODE: MECHANICAL (G04) - IM NAIL VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE DEVICE IS FRACTURED, HOWEVER AS THE PRODUCT WAS NOT RETURNED FURTHER VISUAL AND DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) . MEDICAL PRODUCTS: ITEM#: 14-405034, TI-DBLE LEAD CORT 5.0X34MM SCR; LOT#: 682140. ITEM#: 14-405046, TI-DBLE LEAD CORT 5.0X46MM SCR; LOT#: 279990. ITEM#: 14-405032, TI-DBLE LEAD CORT 5.0X32MM SCR; LOT#: 722300. ITEM#: 14-405046, TI-DBLE LEAD CORT 5.0X46MM SCR; LOT#: 715590. ITEM#: 14-405070, TI-DBLE LEAD CORT 5.0X70MM SCR; LOT#: 365010. ITEM#: 110007912, CANN SCREW 8.0MMX75MMX16MM; LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS REQUESTED BUT NOT RELEASED TO CUSTOMER PER HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLANNED EXPLANTATION OF A SHORT TERM NAIL WHICH WAS BEING REPLACED BY A PLATE. WHILE EXPLANTING THE NAIL THE DISTAL PORTION FRACTURED. NO FOREIGN BODY WAS RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669806 ANKLE LOCKING NAIL 11 X 150MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES/TRAUMA HSB ZIMMER BIOMET, INC. N/A 894840 00887868093593

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male