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

Model Number	6875
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an elderly female patient undergoing anterior hip arthroplasty suffered tibia fracture which required extra surgery and longer hospital stay.The table was being operated by implant rep during the surgical procedure.
Event or Problem Description
It was reported that an elderly female patient ungergoing anterior hip arthroplasty suffered tibia fracture which required extra surgery and longer hospital stay.The table was being operated by implant rep during the surgical procedure.
Additional Manufacturer Narrative
Per the information obtained from the investigation, no problems were found with the device itself.The observed tibia fracture is suspected to be a result of a counter pressure being generated during applied traction through the traction boot and/or femoral hooks while internally rotating the foot during a hip procedure.This combined along with the pre-existing patient condition of osteoporosis (brittle bones) could have caused or contributed to the tibia fracture.

• 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 94587-1234 ; 5104291500
• MDR Report Key: 19558631
• Report Number: 2921578-2024-00006
• Device Sequence Number: 4812007
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: Other
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/06/2024
• 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: Required Intervention; Hospitalization
• Patient Sex: Female