MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA CLEARTRAC THREADED 8.5 X 45MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72200904

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A visual inspection of the device confirmed the reported breakage.The very distal tip of the obturator has broken off.The broken portion was not returned.The break area indicates that the obturator came in contact with a metal or boney surface causing the breakage.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

During an arthroscopic capsular application of the right shoulder the cannula was inserted in the usual manner through tough tissue.No issues were observed with the cannula prior to insertion.On removal of the obturator and viewing of the joint it was noticed that there was a piece of the plastic tip of the obturator inside the joint.The surgeon flushed this out of the joint using the pump and fluid and was the piece was no longer in the patient.He viewed the area with the scope.No patient injury or other complications were reported.

• Brand Name: CANNULA CLEARTRAC THREADED 8.5 X 45MM
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5971950
• MDR Text Key: 55697585
• Report Number: 1219602-2016-00915
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2015

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
• Device Operator: Other
• Device Expiration Date: 10/15/2017
• Device Catalogue Number: 72200904
• Device Lot Number: 904141115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2015
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1