MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CLEAR-TRAC COMPLETE DISPOSABLE CANNULA SYSTEM, 8.5MM X 72MM THREADED; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72200903

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The procedure was an instability slap repair and biceps transfer.On correct initial placement of the clear-trac threaded cannula into the shoulder, it was observed through the scope that there was a small piece of green fragment apparently from the obturator.An incisor plus platinum shaver blade was inserted to attempt removal and the fragment moved to out of sight.The consultant looked around the joint using the scope and the fragment could no longer be located.He proceeded with the surgery.During the biceps transfer the shoulder was open, this was normal and expected, and the fragment could not be found.Cannula and obturator will be returned for analysis however on inspection after surgery, it was not obvious where this piece had come from.No delay to surgery.

Manufacturer Narrative

Device returned to the manufacturer on 17 december, 2015.Evaluation narrative - one 8.5 x 72mm cleartrac threaded cannula was returned for evaluation.Visual assessment of the device confirmed the reported breakage.The very distal tip of the obturator has broken off.Broken portion was not returned.The break area indicates that the obturator came in contact with a metal or boney surface causing the breakage.A review of the complaint database confirmed this incident to be isolated in nature.No additional actions are warranted at this time.Device was evaluated by the manufacturer.(b)(4).

• Brand Name: CLEAR-TRAC COMPLETE DISPOSABLE CANNULA SYSTEM, 8.5MM X 72MM THREADED
• 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: james gonzales ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585706
• MDR Report Key: 5303966
• MDR Text Key: 33713827
• Report Number: 1219602-2015-01257
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Catalogue Number: 72200903
• Device Lot Number: 903150905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention