MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA CLEARTRAC THREADED 7.0 X 72MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72200905
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the cannula had been bent.A back up device was available to complete the procedure , a delay greater than 30 minutes was reported.No patient injuries were reported.
Additional Manufacturer Narrative
Twenty-three 7.0 x 72mm clear-trac threaded cannulas were returned for evaluation.Visual assessment of the devices confirmed the reported complaint.The cannulas are all bent to varying degrees.This is an acknowledged failure mode that has been evaluated and is being monitored.
Additional Manufacturer Narrative
The initial incident report was submitted with incorrect manufacturing site registration number (b)(4) (s+n (b)(6)).The correct manufacturing site registration number is (b)(4)(s+n (b)(6)).Corrected data: g1 contact information.

• Brand Name: CANNULA CLEARTRAC THREADED 7.0 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8647039
• Report Number: 1020279-2019-02085
• Device Sequence Number: 2663066
• Product Code: NBH
• UDI-Device Identifier: 03596010595133
• UDI-Public: 03596010595133
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2020

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: 06/14/2020
• Device Model Number: 72200905
• Device Catalogue Number: 72200905
• Device Lot Number: 905170614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/19/2019; 02/08/2020
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/20/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1