MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, CURVED, HL 4.2MM X 19CM; SAW BLADE

Model Number	DISSECTOR, CURVED, HL 4.2MM X 19CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
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 19-dec-2025, it was reported by a sales representative via (b)(4) that (qty.2) of an ar-6420cds curved dissectors left metal shavings behind.This was discovered during the case with no patient harm.Additional information was provided by the rep on 23-dec-25, that this was discovered during a hip scope.The shavings were discovered during the debridement of labrum.All fragments were retrieved.Both suction and irrigation were used, and no alarms were present.Another device was used to complete the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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, and/or side loading during use.

• Brand Name: DISSECTOR, CURVED, HL 4.2MM X 19CM
• 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: 24052835
• Report Number: 1220246-2026-00185
• Device Sequence Number: 15958369
• Product Code: GFA
• UDI-Device Identifier: 00888867039193
• UDI-Public: (01)00888867039193(11)250828(17)300731(10)15489812
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 04/21/2026

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, CURVED, HL 4.2MM X 19CM
• Device Catalogue Number: AR-6420CDS
• Device Lot Number: 15489812
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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