MAUDE Adverse Event Report: ARTHREX, INC. CON OBT F/ I/O SYNERGY 4MM SCOPE SHEATH; ARTHROSCOPIC ACCESSORIES

Model Number	CON OBT F/ I/O SYNERGY 4MM SCOPE SHEATH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/16/2025, it was reported by a facility representative via (b)(4) that an ar-3375-4005 sheath is broken, no further information was provided.This occurred during use in a case with no patient impact.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to the misuse/mishandling of the device due to prying and leveraging the device during use.

• Brand Name: CON OBT F/ I/O SYNERGY 4MM SCOPE SHEATH
• 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: 23391076
• Report Number: 1220246-2025-04831
• Device Sequence Number: 15920631
• Product Code: NBH
• UDI-Device Identifier: 00888867101609
• UDI-Public: (01)00888867101609(11)211005(10)1660604
• 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): 03/02/2026

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: CON OBT F/ I/O SYNERGY 4MM SCOPE SHEATH
• Device Catalogue Number: AR-3375-4005
• Device Lot Number: 1660604
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2021
• 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