MAUDE Adverse Event Report: MIZUHO OSI HANA LEG SPAR; LEG POSITIONER

Model Number	6875-3700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Traction unit broke at weld.
Additional Manufacturer Narrative
Evaluation of the device was performed by the manufacturer and it was found that the device had scratches, cracked knob and a bent handle.Hence , it was deemed that the device might have been mishandled/dropped causing the leg spar to break.Evaluation of the weld joint concluded that it was insufficient and the fillet metals did not have enough penetration inside the joint.A supplier corrective action has been initiated to address this issue.
Event or Problem Description
Traction unit broke at weld.

• Brand Name: HANA LEG SPAR
• Common Device Name: LEG POSITIONER
• 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 avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 19510513
• Report Number: 2921578-2024-00004
• Device Sequence Number: 19724332
• Product Code: JEA
• UDI-Device Identifier: 00842430109003
• UDI-Public: (01)00842430109003
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/14/2024

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: 6875-3700
• Device Catalogue Number: 6875-3700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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