MAUDE Adverse Event Report: MIZUHO OSI MTS ORTHOPEDIC TRAUMA TOP; OPERATING TABLE

Model Number	5855
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Fell (4014)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/30/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Employee engaged in operating and maintenance activities at a medical center and went into the operating room equipment storage room to organize the equipment for the placement of another table.He attempted to walk between two mizuho osi jackson orthopedic fracture tables (model number 5890) which were used for fractured hip surgery.While repositioning equipment, an unhooked traction arc became loose that caused a positioning leg holder piece to fall.This piece of equipment, which weighted 20 lbs, fell off a tabletop, hitting employee's right foot and injuring his toe.The injury resulted in a serious infection.He was treated at a medical center, where he underwent treatment for the toe infection and was hospitalized.The injury resulted in serious infection and the employee was hospitalized and underwent treatment for toe infection.
Event or Problem Description
Employee engaged in operating and maintenance activities at a medical center and went into the operating room equipment storage room to organize the equipment for the placement of another table.He attempted to walk between two mizuho osi jackson orthopedic fracture tables (model number (b)(6)) which were used for fractured hip surgery.While repositioning equipment, an unhooked traction arc became loose that caused a positioning leg holder piece to fall.This piece of equipment, which weighted 20 lbs, fell off a tabletop, hitting employee's right foot and injuring his toe.The injury resulted in a serious infection.He was treated at a medical center, where he underwent treatment for the toe infection and was hospitalized.
Additional Manufacturer Narrative
Osha inspection nr.(b)(4), report id (b)(6), date opened 04/15/2011 report describes unsecured equipment in storage room falling on employee.

• Brand Name: MTS ORTHOPEDIC TRAUMA TOP
• Common Device Name: OPERATING TABLE
• 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: 17792041
• Report Number: 2921578-2023-00016
• Device Sequence Number: 12607251
• Product Code: JEA
• UDI-Device Identifier: 00842430105999
• UDI-Public: 00842430105999
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Other,Literature,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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?: No
• Operator of Device: Other
• Device Model Number: 5855
• Device Catalogue Number: 5855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male