MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; SURGICAL OPERATING TABLE

Model Number	6875I
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	08/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient fell off the surgery table during surgery.Patient bumped head with no apparent injury.
Additional Manufacturer Narrative
Conclusion of investigation is the users failed to follow the safe patient handling instructions per the owner's manual nw0508: 6.2 patient safety strap.The patient safety strap is designed to secure the patient to the hana® table.Caution: the patient safety strap is intended to secure the patient to the surgical table.It should not be removed unless the patient is being transferred off the table.
Event or Problem Description
It was reported patient fell off the surgery table during surgery.Patient bumped head with no apparent injury.Safety strap was not applied to the patient when she fell off the table.Toe was broken in fall.Total hip arthroplasty as completed successfully at a later date.

• Brand Name: HANA
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8896488
• Report Number: 2921578-2019-00028
• Device Sequence Number: 371908
• Product Code: JEA
• UDI-Device Identifier: 00842430107474
• UDI-Public: 00842430107474
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: Health Professional
• Device Model Number: 6875I
• Device Catalogue Number: 6875I
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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