MAUDE Adverse Event Report: ARTHREX, INC. STOPCOCK,DOUBLE,SPARE,FOR SYNERGY SHEATH; ARTHROSCOPIC ACCESSORIES

Model Number	STOPCOCK,DOUBLE,SPARE,FOR SYNERGY SHEATH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
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 12/03/2024, it was reported by a sales representative via (b)(4) that an ar-3370-0002 stopcock has a valve that broke off of the sheath at the hub.This occurred during use in a case with no patient effect.Another device was used to complete the case.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-3370-0002 serial/batch (b)(6) was received for investigation.Visual inspection noted that the orange o-ring had black grind marks along it.Additionally, one of the stopcock open/close lever has detached from the device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to wear and tear due to repeated use of the device.The manufacturing date is 2017.

• Brand Name: STOPCOCK,DOUBLE,SPARE,FOR SYNERGY 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: 21027883
• Report Number: 1220246-2024-09085
• Device Sequence Number: 15704312
• Product Code: NBH
• UDI-Device Identifier: 00888867029897
• UDI-Public: (01)00888867029897(11)171023(10)1473325
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: STOPCOCK,DOUBLE,SPARE,FOR SYNERGY SHEATH
• Device Catalogue Number: AR-3370-0002
• Device Lot Number: 1473325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown