MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, CURVED 4.0MM X 13CM; SAW BLADE

Model Number	EXCALIBUR, CURVED 4.0MM X 13CM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8400cex, serial/batch (b)(6), was received for investigation.The visual evaluation revealed that after removing the inner shaft from the outer shaft, the tip was broken and lodged inside the outer shaft.Functional testing found that the inner shaft doesn't rotate.The most likely cause (s) of the reported failure are attributed to user error, applying excessive side loading force.
Event or Problem Description
It was reported during the knee arthroscopy that the device stopped working during normal use without any force being applied.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: EXCALIBUR, CURVED 4.0MM X 13CM
• Common Device Name: SAW BLADE
• 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: 23945759
• Report Number: 1220246-2026-00021
• Device Sequence Number: 10758219
• Product Code: GFA
• UDI-Device Identifier: 00888867043503
• UDI-Public: (01)00888867043503(11)250508(17)300430(10)15433050
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 01/02/2026

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: EXCALIBUR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CEX
• Device Lot Number: 15433050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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
• Patient Sex: Unknown