MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA LEG SPAR LIFT ASSIST, LEFT

Model Number	6875-390
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	Perforation (2001); Injury (2348)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported table would not hold its position, therefore the patient was not positioned correctly.This cause reaming through the side wall of the femur.
Event or Problem Description
It was reported table would not hold its position, therefore the patient was not positioned correctly.This cause reaming though the side wall of the femur.
Additional Manufacturer Narrative
Slippage was confirmed, fluid was observed that may have diluted the grease under the rotation index collars causing it to egress into the rotation brake assembly.The grease under the collar looked a little discolored and the texture didn't seem right.Once cleaned slippage was not observed.The customer did not provide the cleaning method for the table.The exact cause could not be determined, did not explain how femur was reamed, did not provide any further details about patient injury or treatment.

• Brand Name: HANA LEG SPAR LIFT ASSIST, LEFT
• Common Device Name: SPAR LIFT
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 10134561
• Report Number: 2921578-2020-00017
• Device Sequence Number: 14358119
• Product Code: JEA
• UDI-Device Identifier: 00842430109010
• UDI-Public: 00842430109010
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: User Facility
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6875-390
• Device Catalogue Number: 6875-390
• Device Lot Number: MIZ200214
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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 Age: 47 YR
• Patient Weight: 96