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

Model Number	T-HANDLE, CANNULATED, LARGE HUDSON
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/03/2021 it was reported by a sales representative via sems that both the 0467-000 blue straight handle and 0468-000 blue t handle were having issues when trying to remove the nail holding bolt.Both of the handles kept spinning without spinning the ball hex driver.A different troch nail set, and new handle were used to remove the bolt.Requested additional information.
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 confirmed.Upon visual inspection, no abnormalities were noted with the device.During functional testing, it was found that the device would come unscrewed from within the blue handle.Based off the information provided, the most likely cause for the reported failure can be attributed to wear and tear.

• Brand Name: T-HANDLE, CANNULATED, LARGE HUDSON
• 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: 19567034
• Report Number: 1220246-2024-06103
• Device Sequence Number: 17879619
• Product Code: LXH
• UDI-Device Identifier: 00848665001969
• UDI-Public: 00848665001969
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/19/2024

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: T-HANDLE, CANNULATED, LARGE HUDSON
• Device Catalogue Number: 0468-000
• Device Lot Number: 141338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 06/19/2024
• 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