MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELITE PREMIUM KNOT MANIPULATOR; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201213

Device Problem Cut In Material (2454)

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

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Ultrabraid no 2 suture was cut while pushing the knot.A backup device was readily available.There was a delay of less then 30 minutes.No patient injuries were reported.

Manufacturer Narrative

Device investigation narrative - one elite premium knot manipulator was returned for evaluation.Visual assessment of the device showed the distal tip to be smooth, no sharp edges.The device was tested using fixture #501448 with two strands of #2 ultrabraid suture.The device did not damage the suture in any manner.This investigation could not identify any evidence of product contribution to the reported complaint.Further investigation is not warranted at this time.

• Brand Name: ELITE PREMIUM KNOT MANIPULATOR
• 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 ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6692183
• MDR Text Key: 79383255
• Report Number: 1219602-2017-00712
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201213
• Device Lot Number: 50504765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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 Age: 50 YR