MAUDE Adverse Event Report: ARTHREX, INC. CON OBT FOR TAP/FEN HF 4MM SCOPE SHEATH; ARTHROSCOPE AND ACCESSORIES

Model Number	CON OBT FOR TAP/FEN HF 4MM SCOPE SHEATH
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Visual evaluation did not showed any damaged or worn.During device testing, device was able to connect and disconnect from the sheath with out difficulty.No problem found.
Event or Problem Description
It was reported on 02/17/2022 by a facility representative via sems that an ar-3375-4007 obturator is "worn out".This was discovered during a case with no patient harm.

• Brand Name: CON OBT FOR TAP/FEN HF 4MM SCOPE SHEATH
• 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: 19260808
• Report Number: 1220246-2024-02898
• Device Sequence Number: 20456167
• Product Code: NBH
• UDI-Device Identifier: 00888867030459
• UDI-Public: 00888867030459
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: CON OBT FOR TAP/FEN HF 4MM SCOPE SHEATH
• Device Catalogue Number: AR-3375-4007
• Device Lot Number: 1429366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2016
• 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