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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b3, b5, h3, h6.
Event or Problem Description
Additional information was received on 04/11/2025: this occurred during an endoscopic interlaminar procedure on (b)(6) 2025.They used a different instrument to grab the broken piece to complete the case.No additional anesthesia was administered to the patient.No adverse effects were reported on the patient.Occurrence date: (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/31/2025, it was reported by a sales representative via (b)(4) that an ar-s7120-025-330w cup grasper w/ teeth had a piece break off into the patient.After about 45 minutes, the surgeon was able to retrieve the broken piece from the patient.Another device was swapped, and the case was completed without adverse effects on the patient.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
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: 21857810
• Report Number: 1220246-2025-01527
• Device Sequence Number: 18103238
• Product Code: LXH
• UDI-Device Identifier: 00888867427495
• UDI-Public: (01)00888867427495(11)231017(10)01577806
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 09/25/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided; 09/22/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 04/28/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown