MAUDE Adverse Event Report: ARTHREX, INC. SABRE, SJ 3.0MM 7CM; SAW BLADE

Model Number	SABRE, SJ 3.0MM 7CM
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
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 07/29/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-7300sr sabre when the device was loaded into the handpiece and used, it made an unusual noise, did not work properly, and the tip turned black from overheating.Adequate irrigation was not used when the device was running.There was no burning or smoking smell.The device began to smoke before use inside the patient.The device was discontinued and the surgery was completed without any problems using a product of the same part number and lot.This occurred before use in a case, during testing of the device, with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-7300sr batch: 15376827 was received for evaluation.Visual inspection revealed that both the tip and the shaft show signs of burning, indicating poor irrigation.A functional test revealed that the inner and outer shafts are stuck together.The most likely cause of the reported and observed failure is user error.The directions for use state that running the device without the flow of irrigation (dry) will cause the device to excessively heat and may result in a thermal burn.Directions for use dfu-0215-eo revision 1.Disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection, and shaverdrill devices.F.Precautions.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.

• Brand Name: SABRE, SJ 3.0MM 7CM
• 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: 22803771
• Report Number: 1220246-2025-03491
• Device Sequence Number: 9063351
• Product Code: GFA
• UDI-Device Identifier: 00888867041974
• UDI-Public: 00888867041974
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/05/2025

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: SABRE, SJ 3.0MM 7CM
• Device Catalogue Number: AR-7300SR
• Device Lot Number: 15376827
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown