MAUDE Adverse Event Report: ARTHREX, INC. CRYSTAL CANNULA, SMOOTH; ACCESSORIES, ARTHROSCOPIC

Model Number	CRYSTAL CANNULA, SMOOTH
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by a sales representative via sems that an ar-6562 crystal cannula broke during a slap debridement with a biceps tenodesis procedure.The dam on the crystal cannula broke resulting in all pieces of the dam falling inside the patients joint space.This was not discovered until operating the shaver inside the joint.The pieces of the dam were noticed and all were retrieved.The case was completed successfully with no harm to the patient.
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: CRYSTAL CANNULA, SMOOTH
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14281651
• Report Number: 1220246-2022-04835
• Device Sequence Number: 14751301
• Product Code: NBH
• UDI-Device Identifier: 00888867040311
• UDI-Public: 00888867040311
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 05/02/2022

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: CRYSTAL CANNULA, SMOOTH
• Device Catalogue Number: AR-6562
• Device Lot Number: 2010118537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 05/04/2022
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown