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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 03/06/2025, a sales representative reported via (b)(4) that an ar-8400cex excalibur snapped during a case.The curved blade was used for some shaving and then to burn mode.It was 1/2 inch below the blade curve when it snapped between bone.No patient was affected.This was discovered during a procedure, with no reported patient harm.Additional information was received on 03/17/2025: ar-8400cex excalibur did produce debris and break.All fragments were retrieved.There was a 60-90-second case delay to open a new shaver blade.The case continued as planned, and another ar-8400cex was used to complete it.No additional anesthesia was administered.There were no adverse effects during or after the surgery.This occurred during a medial patellofemoral repair procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to allowing the rotating portion to touch any metallic object during use, that damage to the device can range from a slight distortion or dulling of the blade/burr edge to actual fracture of the tip in vivo.

• 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: 21699509
• Report Number: 1220246-2025-01142
• Device Sequence Number: 8829163
• Product Code: GFA
• UDI-Device Identifier: 00888867043503
• UDI-Public: 00888867043503
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CEX
• Device Lot Number: 47682440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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