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

Model Number	EXCALIBUR, 4.0MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/07/2025, a facility representative reported via (b)(4) that an ar-8400 ex excalibur had metal shavings flaked off inside of the joint (shoulder) during a shoulder arthroscopy on 7/7/2025.The issue was noticed during the procedure.No adverse effects on the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8400ex, excalibur, 4.0 mm x 13 cm, batch number 15413362, was received for investigation.Visual inspection noted that the device has abrasion marks on the outer hood and shaft.Functional testing was performed and found that the device worked as intended without producing debris filaments.No problem found.The complaint allegation is not confirmed.

• Brand Name: EXCALIBUR, 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: 22663326
• Report Number: 1220246-2025-03131
• Device Sequence Number: 7449374
• Product Code: GFA
• UDI-Device Identifier: 00888867043589
• UDI-Public: 00888867043589
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: EXCALIBUR, 4.0MM X 13CM
• Device Catalogue Number: AR-8400EX
• Device Lot Number: 15413362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown