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	04/22/2025
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 04/22/2025, a sales representative reported via (b)(4) that an ar-s7120-025-330w cup grasper w/ teeth bottom tip of the instrument broke off.This occurred during an interlaminar decompression on (b)(6) 2025 it was stated that the surgeon was not negligent or putting abnormal pressure on the instrument to cause it to break.The fragment was retrieved and the procedure was completed using another cup grasper.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the tip of an ar-s7120-025-330w cup grasper had broken and the fragment was retrieved.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging from repeated usage/reprocessing.Manufactured date: 10-aug-2023.

• 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: 22030088
• Report Number: 1220246-2025-02066
• Device Sequence Number: 15541456
• Product Code: LXH
• UDI-Device Identifier: 00888867427495
• UDI-Public: (01)00888867427495(11)230810(10)01573808
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/04/2025

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: 01573808
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 10/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown