MAUDE Adverse Event Report: ARTHREX, INC. GUIDE PIN, Ø3.2MM X 330MM; INTRAMED FIXATN ROD AND ACCESS

Model Number	GUIDE PIN, Ø3.2MM X 330MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-jan-2026, it was reported by a sales representative via phone that an ar-9094-090l left lag screw, an ar-s0100-381 guide pin, an ar-s0457-000 activation tool, ar-s0100-000 guide pin, ar-s0219-100 drill, ar-s0209-200 drill, ar-9094-11-2030 trochanteric nail, and an ar-9094-085l lag screw were used in a case and neither screw were able to lock into the nail after implantation.All implants were fully explanted and the surgery was completed using a competitor product nail.This occurred during use in a case.Delay in case 50 minutes.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, including the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure was user error, specifically misalignment during screw insertion and/or improper implant positioning.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: GUIDE PIN, Ø3.2MM X 330MM
• 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: 24259242
• Report Number: 1220246-2026-00411
• Device Sequence Number: 9600136
• Product Code: LXH
• UDI-Device Identifier: 00848665000009
• UDI-Public: (01)00848665000009(11)240206(17)291206(10)211926
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 05/19/2026

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: GUIDE PIN, Ø3.2MM X 330MM
• Device Catalogue Number: S0100-000
• Device Lot Number: 211926
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown