MAUDE Adverse Event Report: ARTHREX, INC. C-MOUNT AR-SCOPE,30°1.9X 58MM LGTH; ARTHROSCOPE AND ACCESSORIES

Model Number	C-MOUNT AR-SCOPE,30°1.9X 58MM LGTH
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/4/2023, it was reported by a sales representative via (b)(4) that a ar-3355-1930 endoscope "tip is sharp" noticed during case, no patient affected.
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.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3355-1930 serial/batch number (b)(6) was received for evaluation.A visual inspection revealed that the tip of the instrument has a cut, resulting in a sharp edge.A user error is the most likely cause for the reported and observed failure.Mechanical damage to the device, such as hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.

• Brand Name: C-MOUNT AR-SCOPE,30°1.9X 58MM 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: emily shafer ; 8009337001
• MDR Report Key: 18409882
• Report Number: 1220246-2023-09700
• Device Sequence Number: 8766930
• Product Code: GCJ
• UDI-Device Identifier: 00888867101463
• UDI-Public: 00888867101463
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K941541
• 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,Followup
• Report Date (Section B): 08/21/2024

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°1.9X 58MM LGTH
• Device Catalogue Number: AR-3355-1930
• Device Lot Number: 15028667
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 08/22/2024
• 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