MAUDE Adverse Event Report: ARTHREX, INC. CUP FORCEPS, 3.0 X 330MM, WB; EXEMPT

Model Number	CUP FORCEPS, 3.0 X 330MM, WB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
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 04/23/2025, a facility representative reported via (b)(4)that an ar-s7110-030-330w 3 x 330mm wishbone cup forceps was broken.This was discovered during a case.There were no adverse effects.
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 misuse due to use error/mishandling.

• Brand Name: CUP FORCEPS, 3.0 X 330MM, WB
• Common Device Name: EXEMPT
• 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: 22030257
• Report Number: 1220246-2025-02067
• Device Sequence Number: 8436792
• Product Code: LXH
• UDI-Device Identifier: 00888867427570
• UDI-Public: (01)00888867427570(11)231009(10)01576695
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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 FORCEPS, 3.0 X 330MM, WB
• Device Catalogue Number: AR-S7110-030-330W
• Device Lot Number: 01576695
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• 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: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown