MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.5MM X 13CM; SAW BLADE

Model Number	BONE CUTTER,5.5MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/04/2026
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 04-feb-2026, it was reported by a sales representative via (b)(4) that an ar-8550bc bonecutter was producing metal fragments.This was discovered during a distal clavicle excision procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 -complaint allegation is not confirmed.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.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: BONE CUTTER,5.5MM 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24400483
• Report Number: 1220246-2026-00692
• Device Sequence Number: 8223643
• Product Code: GFA
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 15522554
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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