MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TABLE, HANA, 110 V; OPERATING TABLE

Model Number	6875
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Within 24hrs post procedure it was found that a patient's foot was broken after not being able to apply pressure to stand.This patient had a direct anterior hip preformed, and rotation to the foot had been applied, degree unknown.
Additional Manufacturer Narrative
Per the information obtained from the investigation, no problems were reported with the device itself.Hospital declined to provide any additional information apart from that.Hence the root cause was not established/unknown as is no evidence/indication that points towards anything unusual regarding the patient, surgical procedure or the device usage.
Event or Problem Description
Within 24hrs post procedure it was found that a patient's foot was broken after not being able to apply pressure to stand.This patient had a direct anterior hip preformed, and rotation to the foot had been applied, degree unknown.

• Brand Name: TABLE, HANA, 110 V
• Common Device Name: OPERATING TABLE
• 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 ; 5104291500
• MDR Report Key: 20192234
• Report Number: 2921578-2024-00019
• Device Sequence Number: 12513201
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: (01)00842430108747(21)2020-3185
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2020
• 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: Female