MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. COUPLER II MAIN ASSEMBLY; HEAD/NECK PROCEDURE POSITIONER

Model Number	5873
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Knob assembly of the swivel adapter broke during 180-degree rotation procedure.No patient injury was reported.
Event or Problem Description
Knob assembly of the swivel adapter broke during 180-degree rotation procedure.No patient injury was reported.
Additional Manufacturer Narrative
The lot number of the device in scope was not obtained during the investigation.Thus the age of the device is unknown.Per the available records, the oldest known ship history record for coupler ii to australia is 2012 making it older than the recommended design life of 10 years.Hence there is a remote probability that an older/aged-out model of coupler ii or knob assembly may have been used for the surgical procedure.The pictures of the device shared by the hospital indicate wear and tear and some scratches on it.Owner's manual of the device mention inspecting any components for wear and tear before and after usage and replacing damaged components.There was not enough information obtained during the investigation to point to a specific factor that could have caused the breakage of the knob assembly.Thus root cause of this incident has been deemed as inconclusive.

• Brand Name: COUPLER II MAIN ASSEMBLY
• Common Device Name: HEAD/NECK PROCEDURE POSITIONER
• 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: 23535996
• Report Number: 2921578-2025-00020
• Device Sequence Number: 15994384
• Product Code: JEA
• UDI-Device Identifier: 00842430104534
• UDI-Public: (01)00842430104534
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5873
• Device Catalogue Number: 5873
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown