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

Model Number	4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 02/8/2024, it was reported by a facility representative via (b)(4) that an ar-3355-4031 had sharp edges.This was discovered during a case.The scope was replaced when this problem was discovered.There was case involvement.However, there was no patient harm.
Additional Manufacturer Narrative
Additional information: the complaint allegation was confirmed.One unpackaged ar-3355-4031 was received for evaluation.Visual inspection noted that the tip of the arthroscope was chipped.Completely damaged.Functional testing was not performed due to the damage to the device.The observed condition is most likely the result of interference between the device and other instrumentation or bone during use.

• Brand Name: 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• 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: 18790262
• Report Number: 1220246-2024-01151
• Device Sequence Number: 15517809
• Product Code: HRX
• UDI-Device Identifier: 00888867291751
• UDI-Public: 00888867291751
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 4K C-MOUNT ARTHROSCOPE, 30°,4MM X152.5MM
• Device Catalogue Number: AR-3355-4031
• Device Lot Number: 1612413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• 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