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

Model Number	5840-580
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the investigator, the crack would be seen on inspection, as required before use.But if the user failed to inspect the tray after dropping it and before using it, the crack could be hidden under the pad and, as the crack goes through the material, the tray could break under the weight of a patient.Because a broken tray once led to a patient injury, the chance of recurrence is not considered remote.Based on the results of the investigation, changing this one to reportable.
Event or Problem Description
It was reported that the customer has found a crack that has formed on their chest support section assembly near the corner of the plate portion of the assembly.Investigation found the tray was most likely dropped on one corner, causing the material to crack in that area.The crack would be seen on inspection, as required before use.But if the user failed to inspect the tray after dropping it and before using it, the crack could be hidden under the pad and, as the crack goes through the material, the tray could break under the weight of a patient.Because a broken tray was once reported to have contributed to a patient injury, the chance of recurrence is not considered remote and therefore this damage is being reported.

• Brand Name: TRIOS/STS CHEST PAD SUPPORT PLATE
• Common Device Name: SURGICAL PATIENT POSITIONER
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11633381
• Report Number: 2921578-2021-00011
• Device Sequence Number: 19757350
• Product Code: JEA
• UDI-Device Identifier: 00842430104343
• UDI-Public: 00842430104343
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1