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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
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 a knee surgery the tip of the nitinol pin broke inside the patient without the surgeon applying any particular force.The broken piece was retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device using the other end of the pin.It was not necessary to switch the surgical technique or do a second surgery.

• 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: 25200181
• Report Number: 1220246-2026-02889
• Device Sequence Number: 8889939
• Product Code: MDM
• UDI-Device Identifier: 00888867271593
• UDI-Public: (01)00888867271593(11)260204(17)310131(10)15569607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 07/01/2026

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: NITINOL GUIDE PIN, 1.1 MM
• Device Catalogue Number: AR-1249-1S
• Device Lot Number: 15569607
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2026
• 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