MAUDE Adverse Event Report: ARTHREX, INC. CANNULA, TWIST-IN; ACCESSORIES, ARTHROSCOPIC

Model Number	CANNULA, TWIST-IN
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2021
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
It was reported that during a shoulder arthroscopy surgery the device broke at the edge inside the patient.The broken off piece was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-6530, batch 0066101866 device, along with three sealed ar-6530 devices from the same batch, were received for investigation.When compared to a freshly unpackaged ar-6530 cannula, it was identified that the complaint cannula had been severely bent.Additionally, the distal end of the cannula was chipped.The fragments generated during the event were not returned for analysis.The observed condition is consistent with user applied mechanical damage to the device during use, such as through prying/leveraging the c10155-01 obturator within the cannula during use.The obturator used with the complaint device was not returned for inspection.

• Brand Name: CANNULA, TWIST-IN
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11912004
• Report Number: 1220246-2021-03179
• Device Sequence Number: 11619595
• Product Code: NBH
• UDI-Device Identifier: 00888867040113
• UDI-Public: 00888867040113
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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 Expiration Date: 02/28/2025
• Device Model Number: CANNULA, TWIST-IN
• Device Catalogue Number: AR-6530
• Device Lot Number: 0066101866
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/12/2021
• Patient Sequence Number: 1