MAUDE Adverse Event Report: ARTHREX, INC. COMFORT T-HANDLE, CANNULATED; INTRAMED FIXATN ROD AND ACCESS

Model Number	COMFORT T-HANDLE, CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 02/14/2023 by a sales representative via sems that an 5046-100 capturing rod, 5033-100 capturing rod, and 0468-100 t-handle broke during use.Case involvement, no patient effect.Nothing broke inside patient.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint allegation confirmed based on the photo provided by the reporter.Visual inspection revealed the capturing rod nut was damaged.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: COMFORT T-HANDLE, CANNULATED
• Common Device Name: INTRAMED FIXATN ROD AND 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: jared engle ; 8009337001
• MDR Report Key: 19509393
• Report Number: 1220246-2024-05534
• Device Sequence Number: 7441556
• Product Code: HSB
• UDI-Device Identifier: 00848665037517
• UDI-Public: 00848665037517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: COMFORT T-HANDLE, CANNULATED
• Device Catalogue Number: 0468-100
• Device Lot Number: 190991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown