MAUDE Adverse Event Report: ARTHREX, INC. BRIDGE F/SEALED CANN, 2STPCK F/4MM SCOPE; ARTHROSCOPIC ACCESSORIES

Model Number	BRIDGE F/SEALED CANN, 2STPCK F/4MM SCOPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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 16-dec-2025, it was reported by a facility representative via (b)(4) that an ar-3380-0402 bridge f/sealed cann inflow/outflow piece broke.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-3380-0402 batch 1271505 was received for evaluation.Visual evaluation noted that the stopcock was detached from the sheath at the weld point.Significant signs of wear were noted.A functional test cannot be performed as the device was received broken.The most likely cause of the reported failure is instrument wear and tear.Manufacturing date 2013.The complaint allegation was confirmed.Refer to the investigation pictures.

• Brand Name: BRIDGE F/SEALED CANN, 2STPCK F/4MM SCOPE
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 23961391
• Report Number: 1220246-2026-00070
• Device Sequence Number: 15834782
• Product Code: NBH
• UDI-Device Identifier: 00888867030503
• UDI-Public: (01)00888867030503(11)130220(10)1271505
• 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): 03/10/2026

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: BRIDGE F/SEALED CANN, 2STPCK F/4MM SCOPE
• Device Catalogue Number: AR-3380-0402
• Device Lot Number: 1271505
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2013
• 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