MAUDE Adverse Event Report: ARTHREX, INC. CONICAL OBTURATOR FOR 2.4MM SCOPE SHEATH; ARTHROSCOPE AND ACCESSORIES

Model Number	CONICAL OBTURATOR FOR 2.4MM SCOPE SHEATH
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
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.Upon visual inspection, it was noted that the device was received assembled to an ar-3372-2402.Once disassembled, no bend or abnormalities were noted with the device.Device was able to be taken apart and reassembled to the ar-3372-2402 with no issue.
Event or Problem Description
It was reported that during a hand arthroscopy the obturator of the 2.4mm optic appears to be slightly bent and jammed in the shaft.No part of the device broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: CONICAL OBTURATOR FOR 2.4MM 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: 19260901
• Report Number: 1220246-2024-02902
• Device Sequence Number: 6614415
• Product Code: NBH
• UDI-Device Identifier: 00888867030312
• UDI-Public: 00888867030312
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• 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: CONICAL OBTURATOR FOR 2.4MM SCOPE SHEATH
• Device Catalogue Number: AR-3375-2407
• Device Lot Number: 1467181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2018
• 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