MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNOT MANIPULATOR QUICK-T; ACCESSORIES,ARTHROSCOPIC

Catalog Number 7210116

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/17/2014

Event Type  malfunction  

Manufacturer Narrative

The device was visually inspected under high magnification.No burrs and/or sharp edges were found.The device was functionally tested and it showed that the device did not cut the suture.After the evaluation a definitive root cause for the reported issue could not be determined.A review of the device history records and complaint files confirmed that no additional complaints have been reported and no abnormalities were noted during the manufacturing process for this lot.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that during the case the healthcare professional was tying the knot, and while pushing with the knot pusher, the suture was cut.This happened same event happened twice.It was also reported that each time the suture got cut, a new anchor was required.There were no reported patient injuries.No other complications were noted.

• Brand Name: KNOT MANIPULATOR QUICK-T
• 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: 5975934
• MDR Text Key: 55907027
• Report Number: 1219602-2016-01067
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/17/2014

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: 7210116
• Device Lot Number: 50465095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 09/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1