MAUDE Adverse Event Report: Arthrex, Inc. ES troch nail, Rt, 10mm x 42cm x 125°; INTRAMED FIXATN ROD AND ACCESS

Model Number	ES troch nail, Rt, 10mm x 42cm x 125°
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury

• Brand Name: ES troch nail, Rt, 10mm x 42cm x 125°
• Common Device Name: INTRAMED FIXATN ROD AND ACCESS
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50226592
• Report Number: 1220246-2026-04306
• Device Sequence Number: 13330445
• Product Code: HSB
• UDI-Device Identifier: 00888867412224
• UDI-Public: (01)00888867412224(11)250204(17)300131(10)15383776
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ES troch nail, Rt, 10mm x 42cm x 125°
• Device Catalogue Number: AR-9094ES-10-4225R
• Device Lot Number: 15383776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Supplement Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown