MAUDE Adverse Event Report: ARTHREX, INC. DRILL TIP GUIDE PIN 2.4 MM X 311 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	DRILL TIP GUIDE PIN 2.4 MM X 311 MM
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/03/2025, it was reported by an arthrex employee via (b)(4) that an ar-1250ls drill tip guide pin sleeve rotated along with the drill.This was discovered during the case.Another device was used to complete the case with no 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.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to determine a most likely cause.The most likely cause for the reported failure is user error due to improper engagement or locking of the sleeve.

• Brand Name: DRILL TIP GUIDE PIN 2.4 MM X 311 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: 22610931
• Report Number: 1220246-2025-03092
• Device Sequence Number: 14826371
• Product Code: MDM
• UDI-Device Identifier: 00888867006270
• UDI-Public: (01)00888867006270(11)240806(17)290331(10)370313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/07/2025

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: DRILL TIP GUIDE PIN 2.4 MM X 311 MM
• Device Catalogue Number: AR-1250LS
• Device Lot Number: 370313
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown