MAUDE Adverse Event Report: ARTHREX, INC. TRIMANO FORTIS REUSABLE LEG HOLDER; OPERATING ROOM TABLE ACCESS

Model Number TRIMANO FORTIS REUSABLE LEG HOLDER

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems that an ar-1747-b reusable leg holder was bent during the case.The issue was discovered after the case, and there was no patient effect reported.

Manufacturer Narrative

Complaint is confirmed.Visual evaluation noted that the trimano fortis reusable leg holder was bent.The most likely cause of this failure is applying excessive force through leveraging the device.

• Brand Name: TRIMANO FORTIS REUSABLE LEG HOLDER
• Type of Device: OPERATING ROOM TABLE ACCESS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 17697690
• MDR Text Key: 322811114
• Report Number: 1220246-2023-07795
• Device Sequence Number: 1
• Product Code: BWN
• UDI-Device Identifier: 00888867290808
• UDI-Public: 00888867290808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Model Number: TRIMANO FORTIS REUSABLE LEG HOLDER
• Device Catalogue Number: AR-1747-B
• Device Lot Number: 68750168
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1