MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS/STS CHEST PAD SUPPORT PLATE

Model Number	5840-580
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the chest support assembly broke with a patient on the table.Patient was not injured.Break was at top of the side walls on both sides where it starts the attachment over the table rails.Velcro to secure to the tabletop was missing on both sides.
Additional Manufacturer Narrative
The broken equipment was not sent back.Based on purchasing history, it was at least 8 years old.Based on the photos provided, the device was damaged, straps missing, additional velcro glued on.Owner's manual says, "warning: before and after each use, inspect the table top, components, and accessories for possible damage, excessive wear, or non-functioning parts.Carefully inspect all critical, accessible areas, joints, and all moving parts for possible damage or non-function.Damaged or defective parts should not be used or processed.Contact mizuho osi service for repair or replacement.".
Event or Problem Description
It was reported that the chest support assembly broke with a patient on the table.Patient was not injured.Break was at top of the side walls on both sides where it starts the attachment over the table rails.Velcro to secure to the tabletop was missing on both sides.

• Brand Name: TRIOS/STS CHEST PAD SUPPORT PLATE
• Common Device Name: SUPPORT PLATE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city, ca
• MDR Report Key: 9811120
• Report Number: 2921578-2020-00013
• Device Sequence Number: 16894579
• Product Code: JEA
• UDI-Device Identifier: 00842430104343
• UDI-Public: 00842430104343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 5840-580
• Device Catalogue Number: 5840-580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1