MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CLEAR TRAC COMP 8.5X72MM DSP CANN; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7209984

Device Problem Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 09/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip of the clear trac complete 8.5 x 72 mm disposable cannula had what looked like a loose piece of plastic.A needle was used to dislodge the piece that was then discarded.Nothing fell into the patient and no delay occurred as a result.An alternative device was used to complete the procedure.

Manufacturer Narrative

Visual examination of the device confirmed the reported complaint.A small piece of the valve stem has skived free.Root cause cannot be determined with confidence.A review of the complaint database was performed which found this failure mode to be isolated in nature.

• Brand Name: CLEAR TRAC COMP 8.5X72MM DSP CANN
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5993673
• MDR Text Key: 56605510
• Report Number: 1219602-2016-01132
• 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,Followup
• Report Date: 09/05/2016

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: Health Professional
• Device Catalogue Number: 7209984
• Device Lot Number: 903150929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2016
• Initial Date FDA Received: 10/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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