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	Burn(s) (1757)
Date of Event	08/01/2025
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 (b)(6) 2025, it was reported by a facility representative via (b)(4).The surgeon was using the arthroscopy shaver 3.0mm sabre ar-7300sr outside of scoping to debride the cartilage when the single-use shaver blade sparked and burned the patient¿s bone.Additional information was received on 14-aug-2025: the reporter clarified that there was a small isolated burn to the patient¿s bone which was removed immediately after the incident occurred.A rongeur was used to complete that part of the procedure.Additional information was received on 19-aug-2025: the reporter stated that the incident occurred due to the lack of irrigation when the surgeon was debriding the cartilage.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-7300sr batch 15375361 was received for evaluation.Visual inspection revealed that both the tip and the shaft show signs of burning, indicating poor irrigation.The functional test was not performed due to damage to the device.The tubes 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: 22872308
• Report Number: 1220246-2025-03582
• Device Sequence Number: 21425462
• Product Code: GFA
• UDI-Device Identifier: 00888867041974
• UDI-Public: (01)00888867041974(11)250120(17)291231(10)15375361
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 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: 15375361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown