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	09/20/2024
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 09/20/2024, it was reported by a facility representative via sems-06668583 that an ar-3370-0002 stopcock, double, spare, for synergy hd3 sheath lever broke off during a case.There was no harm to the patient.This was discovered during a procedure.Additional information was requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-3370-0002 stopcock lot number: 1300497 was received for investigation.Visual evaluation noted that one of the levers of the returned device was damaged and had fallen apart.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to to overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

• 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: 20367621
• Report Number: 1220246-2024-07988
• Device Sequence Number: 11684755
• Product Code: NBH
• UDI-Device Identifier: 00888867029897
• UDI-Public: 00888867029897
• 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): 01/27/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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