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

Model Number	DISSECTOR, SJ 3.0MM X 7CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/29/2025, a facility representative reported via (b)(4) that an ar-7300ds 3mm x 7cm dissector had metal shavings/specs of metal that came off as it shaved the bone during an ankle arthroscopy procedure.They were able to use a suction to get the metal shavers out of the patient, who was unaffected.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to use-related factors, specifically excessive side-loading during use.This determination is consistent with the precautions described in dfu-0215-eo, revision 1 ¿ disposable arthroscopic shaver blades, burrs, powerpick¿, powerasp¿, nanoresection¿, and shaverdrill¿ devices, which state: f.Precautions (6) do not allow the rotating portion of any device to contact metallic objects (e.G., cannulas, arthroscopes).Such contact may cause damage ranging from edge dulling to fracture of the tip.If contact occurs, inspect the device and replace it if cracks, fractures, or dulling are observed.(7) excessive side-loading during use does not improve cutting performance and may cause irreversible damage to the device.(8) excessive loading on the powerasp device may disengage the cam mechanism and stall cutting effectiveness.

• Brand Name: DISSECTOR, SJ 3.0MM X 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: 23541917
• Report Number: 1220246-2025-05060
• Device Sequence Number: 9718813
• Product Code: GFA
• UDI-Device Identifier: 00888867041943
• UDI-Public: (01)00888867041943(11)250625(17)300531(10)15456062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/06/2026

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: DISSECTOR, SJ 3.0MM X 7CM
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 15456062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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