MAUDE Adverse Event Report: ARTHREX, INC. SHEATH, 1 STOPCOCK FOR 2.7MM SCOPE; ARTHROSCOPE AND ACCESSORIES

Model Number	SHEATH, 1 STOPCOCK FOR 2.7MM SCOPE
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 05/07/2024 it was reported by a sales representative via (b)(4) that an ar-3372-2701 sheath is cracked, which will not allow obturators to be removed.This occurred during use in a case with no patient effect.

• Brand Name: SHEATH, 1 STOPCOCK FOR 2.7MM SCOPE
• Common Device Name: ARTHROSCOPE AND 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: 19461067
• Report Number: 1220246-2024-04856
• Device Sequence Number: 7972896
• Product Code: NBH
• UDI-Device Identifier: 00888867198487
• UDI-Public: 00888867198487
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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, 1 STOPCOCK FOR 2.7MM SCOPE
• Device Catalogue Number: AR-3372-2701
• Device Lot Number: 1596567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2020
• 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