MAUDE Adverse Event Report: ARTHREX, INC. NITINOL GUIDE PIN, 1.1 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	NITINOL GUIDE PIN, 1.1 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery while the surgeon was removed the guide the tip broke off.The surgeon took a x-ray picture and identified that the tip remained inside the patient.The surgeon attempted to remove the broken tip through arthroscopy for one hour but was unsuccessful and decided then to open the wound to remove the broken tip.

• Brand Name: NITINOL GUIDE PIN, 1.1 MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 24631672
• Report Number: 1220246-2026-01484
• Device Sequence Number: 8852821
• Product Code: MDM
• UDI-Device Identifier: 00888867271593
• UDI-Public: (01)00888867271593(11)251103(17)301031(10)15524285
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: NITINOL GUIDE PIN, 1.1 MM
• Device Catalogue Number: AR-1249-1S
• Device Lot Number: 15524285
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown