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

Model Number	CUP GRASPER, TEETH, 2.5 X 330MM, WB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2025
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 03/13/2025, a sales representative via (b)(4) reported that an ar-s7110-030-330w cup forceps and the ar-s7120-025-330w cup grasper malfunctioned during a case.The ar-s7120-025-330w distal tip broke off in the disc space.The broken piece was eventually identified and removed from the patient.The ar-s7110-030-330w will no longer close.These issues occurred while performing a discectomy at l5/s1 under normal working conditions.Other pituitaries were used to continue and complete the case without issue.The case was not delayed significantly due to the breakage.The surgery was completed as intended.
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 for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: CUP GRASPER, TEETH, 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: 21754786
• Report Number: 1220246-2025-01184
• Device Sequence Number: 8235677
• Product Code: LXH
• UDI-Device Identifier: 00888867427495
• UDI-Public: (01)00888867427495(11)231017(10)01577806
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/22/2025

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 GRASPER, TEETH, 2.5 X 330MM, WB
• Device Catalogue Number: AR-S7120-025-330W
• Device Lot Number: 01577806
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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