MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72200829

Device Problem Leak/Splash (1354)

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

Event Date 11/25/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Examination was not possible, as the device was not returned.A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints of this nature have been filed and that no abnormalities were reported with this product during manufacture.(b)(4).

Event Description

Functional - leaking there was a leakage in the cannula.Follow up received: the procedure was an acl reconstruction.A backup device was not available; the case was completed with the complaint device.There was no reported delay, patient injury or complication.Additional information received: the subject hd cannula (b)(4) which was more than 2 years old, was inspected by our service center with the complaint for leakage.The same was rectified by tightening of the screw on the inflow /outflow value and returned back to customer.

• Brand Name: CANN, H.F.,DGNST, 6MM, RTBL, DBL VLV
• 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: 5224670
• MDR Text Key: 31459062
• Report Number: 1219602-2015-01186
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200829
• Device Lot Number: 50345187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1