MAUDE Adverse Event Report: Arthrex, Inc. Dissector, 3.0mm x 7cm; SAW BLADE

Model Number	Dissector, 3.0mm x 7cm
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic wrist surgery the device produced metal shaving while removing remnants of the sl ligament that prolapsed into the joint.The surgeon tried to remove the metal shaving, but he did not succeed.Some fragments remained in the patient's knee.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed by the attached picture, which shows particles of debris on the pictures.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.Per dfu-0215-eo- rev 1 - f - precautions 6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.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.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.The most likely cause is attributed to misuse of the device, including exposure to excessive mechanical forces, misaligned insertion, side loading during use and/or allowing the rotating portion to touch any metallic object during use.

• Brand Name: Dissector, 3.0mm x 7cm
• Common Device Name: SAW BLADE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50866746
• Report Number: 1220246-2026-04858
• Device Sequence Number: 9223460
• Product Code: GFA
• UDI-Device Identifier: 00888867211834
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 09/23/2026

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, 3.0mm x 7cm
• Device Catalogue Number: AR-9300DS
• Device Lot Number: 15622062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2026
• 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