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 Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4th nov 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-8400ex, excalibur, 4.0 mm x 13 cm, it was bent when using it to do synovial membrane cleaning.This was detected during a rotator cuff repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-8400ex.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-8400ex batch 15253484 was received for evaluation.Visual inspection revealed that excalibur's shaft was bent.No other damage was noted.A functional test was not performed due to the device's damage.The most likely cause of the reported failure was determined to be user error, including the application of excessive bending forces.

• 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: 23629985
• Report Number: 1220246-2025-05149
• Device Sequence Number: 13357288
• Product Code: GFA
• UDI-Device Identifier: 00888867043589
• UDI-Public: (01)00888867043589(11)240524(17)290430(10)15253484
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/03/2026

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, 4.0MM X 13CM
• Device Catalogue Number: AR-8400EX
• Device Lot Number: 15253484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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