MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,30°4X152.5MM LGTH; ARTHROSCOPE AND ACCESSORIES

Model Number	C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
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.See attached vendor evaluation.
Event or Problem Description
On 11/9/2021, it was reported by a sales representative via sems that an ar-3355-4030 scope had a sharp tip.This was discovered during a knee scope procedure, and patient was not affected.

• Brand Name: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• 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: 19498297
• Report Number: 1220246-2024-05387
• Device Sequence Number: 12721054
• Product Code: HRX
• UDI-Device Identifier: 00888867029842
• UDI-Public: 00888867029842
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: C-MOUNT AR-SCOPE,30°4X152.5MM LGTH
• Device Catalogue Number: AR-3355-4030
• Device Lot Number: 13108208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 06/10/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown