MAUDE Adverse Event Report: ARTHREX, INC. CUP FORCEPS, 2.5 X 330MM, WB; RONGEUR

Model Number	CUP FORCEPS, 2.5 X 330MM, WB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
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 (b)(6), a sales representative reported via sems-(b)(4) that the ar-s7110-025-330w cup forceps had the top piece of the jaw break off, outside of the patient.This issue was discovered during a case with no patient harm.

• Brand Name: CUP FORCEPS, 2.5 X 330MM, WB
• Common Device Name: RONGEUR
• 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: 24621408
• Report Number: 1220246-2026-01474
• Device Sequence Number: 16008584
• Product Code: LXH
• UDI-Device Identifier: 00888867427518
• UDI-Public: (01)00888867427518(11)250211(10)01610438
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/10/2026

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: CUP FORCEPS, 2.5 X 330MM, WB
• Device Catalogue Number: AR-S7110-025-330W
• Device Lot Number: 01610438
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown