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

Model Number	CUP FORCEPS, 2.5 X 330MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 03-mar-2026, it was reported by a sales representative via (b)(4) that an ar-s7110-025-330 cup forceps grasper broke inside of the patient.This was discovered during a procedure with no patient harm and no effect on the case.Additional information provided 05-mar-2026: it was further reported this occurred during an l4/5 endoscopic microdiscectomy and was completed with a 3.0 grasper.No case delay and no additional anesthesia was administered.All fragments were retrieved from the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: CUP FORCEPS, 2.5 X 330MM
• 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: 24665196
• Report Number: 1220246-2026-01604
• Device Sequence Number: 17406997
• Product Code: LXH
• UDI-Device Identifier: 00888867427624
• UDI-Public: (01)00888867427624(11)230217(10)01558586
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 07/09/2026

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
• Device Catalogue Number: AR-S7110-025-330
• Device Lot Number: 01558586
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown