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	Insufficient Information (4580)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
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 not confirmed.Upon visual inspection, no abnormalities were noted with the device.During functional testing, it was found that the device functioned as required.
Event or Problem Description
On 01/10/2022 it was reported by a sales representative via sems that the 1239-100 locking knob (line #1) is stuck into the 1235-100 insertion guide (line #2) and the 0468-100 t-handle (line #3) broke while trying to remove the locking knob.

• 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: 19398050
• Report Number: 1220246-2024-03925
• Device Sequence Number: 7753929
• Product Code: HSB
• UDI-Device Identifier: 00848665037517
• UDI-Public: 00848665037517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/24/2024

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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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