MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA/PROFX TRACTION BOOT XLARGE (PR)

Model Number	6850-487
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907); Component Misassembled (4004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the customer was using the hana table for a anterior hip replacement case.When the rn in the room pulled traction for the surgeon during the case, the allen screw that was holding the base plate to the boot broke apart, and the boot was left swinging with the patient's foot still attached in boot.Nurse went under the drapes to secure the patients foot and immediately changed the boot on the patient's foot.We noticed after the case that the boot was incorrectly manufactured with two washers placed on the boot and not allowing the allen screw enough threads to hold the weight placed upon it.
Additional Manufacturer Narrative
Investigation of the returned parts found that when they were reassembled with the extra washer in place, the fastener was not fully engaged.Review of the customer purchase history showed that the original boots were purchased over five years ago.It appears that over time the fastener loosened and then fell out.Review of the product complaint history shows no similar instances.The cause appears to be an isolated human error in manufacturing.
Event or Problem Description
It was reported the customer was using the hana table for a anterior hip replacement case.When the rn in the room pulled traction for the surgeon during the case, the allen screw that was holding the base plate to the boot broke apart, and the boot was left swinging with the patient's foot still attached in boot.Nurse went under the drapes to secure the patients foot and immediately changed the boot on the patient's foot.We noticed after the case that the boot was incorrectly manufactured with two washers placed on the boot and not allowing the allen screw enough threads to hold the weight placed upon it.

• Brand Name: HANA/PROFX TRACTION BOOT XLARGE (PR)
• Common Device Name: TRACTION BOOT
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 7544879
• Report Number: 2921578-2018-00018
• Device Sequence Number: 16175718
• Product Code: JEA
• UDI-Device Identifier: 00842430106491
• UDI-Public: 00842430106491
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: 6850-487
• Device Catalogue Number: 6850-487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1