MAUDE Adverse Event Report: ARTHREX, INC. CONIC OBTR,FOR 4MM SCOPE SHTH; ARTHROSCOPE AND ACCESSORIES

Model Number	CONIC OBTR,FOR 4MM SCOPE SHTH
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
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.The complaint is confirmed.Device was received: ar-3375-4011, batch 1456758, unpackaged.Observation revealed discoloration consistent with rust and pitting along the shaft of the device.The cause of this event is most likely wear due to age.
Event or Problem Description
It was reported that there is pitting corrosion with this device.There was no harm for patient, operator or third-party reported.No further information was received.

• Brand Name: CONIC OBTR,FOR 4MM SCOPE SHTH
• 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: 19191212
• Report Number: 1220246-2024-02445
• Device Sequence Number: 8473785
• Product Code: NBH
• UDI-Device Identifier: 00888867101616
• UDI-Public: 00888867101616
• 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): 04/26/2024

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: CONIC OBTR,FOR 4MM SCOPE SHTH
• Device Catalogue Number: AR-3375-4011
• Device Lot Number: 1456758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• 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