MAUDE Adverse Event Report: ARTHREX, INC. ANATOMIC CONTOUR PCL TIBIAL GUIDE, LEFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	ANATOMIC CONTOUR PCL TIBIAL GUIDE, LEFT
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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
On 16-dec-2025, it was reported by a sales representative via (b)(4) that an ar-1510ptl anatomic contour pcl left tibial guide was dull.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to wear and tear damage sustained over time in the field.The manufacturing date is 2012.

• Brand Name: ANATOMIC CONTOUR PCL TIBIAL GUIDE, LEFT
• 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: 23962255
• Report Number: 1220246-2026-00073
• Device Sequence Number: 21144779
• Product Code: MDM
• UDI-Device Identifier: 00888867018419
• UDI-Public: (01)00888867018419(10)71451214
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 04/17/2026

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: ANATOMIC CONTOUR PCL TIBIAL GUIDE, LEFT
• Device Catalogue Number: AR-1510PTL
• Device Lot Number: 71451214
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown