MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE; ACCESSORIES, ARTHROSCOPIC

Model Number	SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/30/2022, a medwatch notification was received via email that a small piece of the obturator from an ar-3372-4002 scope sheath, broke off and entered the patient.The surgeon was able to remove the broken fragment and used a new ar-3372-4002 scope sheath to complete the case.This was discovered during a procedure on (b)(4) 2022.No additional information has been provided.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos provided.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.

• Brand Name: SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16173489
• Report Number: 1220246-2023-06130
• Device Sequence Number: 14538320
• Product Code: NBH
• UDI-Device Identifier: 00888867198531
• UDI-Public: 00888867198531
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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: SHEATH, HF, 2 STOPCOCK FOR 4MM SCOPE
• Device Catalogue Number: AR-3372-4002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown