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

Model Number 6875

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Skin Tears (2516)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

The exact nature of the injury remains unclear.We are reporting it because we don't know if it might be serious.Definitive root cause not determined due to limited details available.Based on the patient's demographic, the cause of abrasion could be the combination of a "hospital sock" that could have been in conflict with the boot liner, and/or the over-tightening of boot on an already frail, geriatric patient.

Event Description

It was reported patient was being surgically treated for a hip fracture utilizing a gamma nail.Traction was applied for the procedure, specifically how much traction or for how long is not known.It was not documented which boot size was used, but the nurse thinks it was most likely the large size boot.The black reusable boot liners were utilized during the case, in addition the patient had on "no slip hospital socks" in between the patient's skin and the boot liner.The wound occurred within the part of the leg contained in the boot.The patient was initially treated with a wound vac, and then was transferred to a rehab facility so the status of the injury today is not known.

• Brand Name: HANA
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 9238326
• MDR Text Key: 164243262
• Report Number: 2921578-2019-00036
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 96 YR
• Patient Weight: 50