MAUDE Adverse Event Report: ARTHREX, INC. METAL CANNULA, FENESTRATED, 5.0MM; ARTHROSCOPE AND ACCESSORIES

Model Number	METAL CANNULA, FENESTRATED, 5.0MM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/10/2023, it was reported by a sales representative via sems that an ar-3425-5.0 metal cannula is bent.This was discovered during a case with no patient effect.
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.

• Brand Name: METAL CANNULA, FENESTRATED, 5.0MM
• 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: 17479945
• Report Number: 1220246-2023-07447
• Device Sequence Number: 11440987
• Product Code: NBH
• UDI-Device Identifier: 00888867214330
• UDI-Public: 00888867214330
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/08/2023

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: METAL CANNULA, FENESTRATED, 5.0MM
• Device Catalogue Number: AR-3425-5.0
• Device Lot Number: 1425345
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 08/08/2023
• Date Device Manufactured: 09/22/2016
• 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