MAUDE Adverse Event Report: ARTHREX, INC. HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM; ARTHROSCOPE AND ACCESSORIES

Model Number	HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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.Event description: it was reported that during the meniscal resection surgery the metal scope part is moving and the light is getting through the scope.The reported event was confirmed as the visual evaluation revealed that the ocular funnel detaches from the main body.Further the distal end and the fiber optics are damaged.The most likely cause for the reported failure can be attributed to misuse of the device.
Event or Problem Description
It was reported that during the meniscal resection surgery the metal scope part is moving and the light is getting through the scope.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.No further information received.

• Brand Name: HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
• 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: 19509448
• Report Number: 1220246-2024-05536
• Device Sequence Number: 18005360
• Product Code: HRX
• UDI-Device Identifier: 00888867029637
• UDI-Public: 00888867029637
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: HD ARTHROSCOPE, 30 DEG, 4 X 152.5MM
• Device Catalogue Number: AR-3350-4030
• Device Lot Number: 1453731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown