MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA LEG SPAR LIFT ASSIST, LEFT; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number	6875-3900
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The hana table would not hold its position, therefore the patient was not positioned correctly.This caused reaming through the side wall of the femur.The gentleman who was called to service the bed seemed to think that the caustic nature of the cleaner may have contributed to the breakdown of the inner mechanisms used to lock the articulating pieces in place.Manufacturer response for table, surgical with orthopedic accessories, ac-powered, hana leg spar lift assist, left (per site reporter).See original description.

• Brand Name: HANA LEG SPAR LIFT ASSIST, LEFT
• Common Device Name: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587
• MDR Report Key: 9990118
• Report Number: 9990118
• Device Sequence Number: 4483239
• Product Code: JEA
• UDI-Device Identifier: 00842430109010
• UDI-Public: (01)00842430109010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2020
• Report Date (Section F): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6875-3900
• Device Catalogue Number: 6875-3900
• Device Lot Number: MIZ200214
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 96
• Date Report Sent to FDA: 03/19/2020