MAUDE Adverse Event Report: ARTHREX, INC. TROCHANTERIC NAIL, RT,10MM X 33CM X 125°; INTRAMED FIXATN ROD AND ACCESS

Model Number	TROCHANTERIC NAIL, RT,10MM X 33CM X 125°
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 15-mar-2026, it was reported by a sales representative via phone that an ar-9094-10-3325r hole for the lag screw was too proximal so screw would not align.Noticed during a case, device swapped, and case completed with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: TROCHANTERIC NAIL, RT,10MM X 33CM X 125°
• 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: 24815044
• Report Number: 1220246-2026-02037
• Device Sequence Number: 9594769
• Product Code: HSB
• UDI-Device Identifier: 00888867411203
• UDI-Public: (01)00888867411203(11)230614(17)280531(10)15104627
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K230257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: TROCHANTERIC NAIL, RT,10MM X 33CM X 125°
• Device Catalogue Number: AR-9094-10-3325R
• Device Lot Number: 15104627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown