MAUDE Adverse Event Report: MIZUHO OSI HANA RADIOLUCENT LEG SPAR LEFT

Model Number	6875-360
Medical Device Problem Codes	Fracture (1260); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while transferring patient to the hana table the spar was noticed to be not locking properly.The spar was still used on the non-operative side and at the end of surgery the non-operative spar fell to the floor while patient's leg was still attached to it.Staff reported that the patient was not harmed.
Event or Problem Description
It was reported that while transferring patient to the hana table the spar was noticed to be not locking properly.The spar was still used on the non-operative side and at the end of surgery the non-operative spar fell to the floor while patient's leg was still attached to it.Staff reported that the patient was not harmed.
Additional Manufacturer Narrative
The locking mechanism was noticed to be defective at the beginning of the procedure.It unlocked at the end of the procedure.The biomed then repaired it, replacing the broken parts.The manual warns the users to inspect the device before and after each use.

• Brand Name: HANA RADIOLUCENT LEG SPAR LEFT
• Common Device Name: LEG SPAR
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 17553214
• Report Number: 2921578-2023-00012
• Device Sequence Number: 17372686
• Product Code: JEA
• UDI-Device Identifier: 00842430106613
• UDI-Public: 00842430106613
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 6875-360
• Device Catalogue Number: 6875-360
• Device Lot Number: 6875 2016 1707
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• 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