MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA/PROFX TRACTION BOOT SMALL (PR)

Model Number	6850-485
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient's leg while inside a traction boot fell during the surgical procedure.The bolt/locking mechanism on the traction boot does not properly secure the boot not lock into place.
Additional Manufacturer Narrative
Per the information obtained from investigation, it was found out that the thumbscrew was removed for unknown reasons and inadvertently replaced/modified by untrained service personnel at the hospital.The patient was found to be doing fine.
Event or Problem Description
It was reported that a patient's leg while inside a traction boot fell during the surgical procedure.The bolt/locking mechanism on the traction boot does not properly secure the boot not lock into place.

• Brand Name: HANA/PROFX TRACTION BOOT SMALL (PR)
• Common Device Name: TRACTION BOOT
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 21366881
• Report Number: 2921578-2025-00002
• Device Sequence Number: 15594547
• Product Code: JEA
• UDI-Device Identifier: 00842430106668
• UDI-Public: (01)00842430106668
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6850-485
• Device Catalogue Number: 6850-485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown