MAUDE Adverse Event Report: ARTHREX, INC. ES TROCH NAIL, LT, 11MM X 39CM X 130°; INTRAMED FIXATN ROD AND ACCESS

Model Number	ES TROCH NAIL, LT, 11MM X 39CM X 130°
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/17/2025, a sales representative reported via (b)(4) that a 1268-100 radiolucent targeting arm, 130 degree troch nail and an ar-9094es-11-3930l es trochanteric nail could not be used as intended.The issue occurred during insertion of the es screw, where the screw trajectory was inaccurate, causing it to bind within the nail.The screw cross-threaded, and the surgeon was unable to fully advance it through the nail.The case was completed without distal locking of the nail.Attempts to align the drill added a delay of approximately five to ten minutes, resulting in an additional five to ten minutes of anesthesia administration.The same original part numbers were used to complete the case.No further information is available.No photos were taken for documentation, and no adverse effects were reported.This issue was identified during a hip fracture procedure on (b)(6) 2025, with no reported patient harm.
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: ES TROCH NAIL, LT, 11MM X 39CM X 130°
• 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: 23356435
• Report Number: 1220246-2025-04749
• Device Sequence Number: 9202746
• Product Code: HSB
• UDI-Device Identifier: 00888867412750
• UDI-Public: 00888867412750
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• 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): 02/24/2026

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: ES TROCH NAIL, LT, 11MM X 39CM X 130°
• Device Catalogue Number: AR-9094ES-11-3930L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown