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

Model Number 72201213

Device Problem Cut In Material (2454)

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

Event Date 06/14/2018

Event Type  malfunction  

Event Description

It was reported that the knot manipulators cut the ultrabraid #2 suture during the knotting.No significant delay or patient injury were reported.A back up was available.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

Manufacturer Narrative

One 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 two strands of #2 braided suture.The device did not damage the suture in any manner.

• 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: 7642100
• MDR Text Key: 112597532
• Report Number: 1219602-2018-00831
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010591272
• UDI-Public: (01)03596010591272(10)50688160
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201213
• Device Catalogue Number: 72201213
• Device Lot Number: 50688160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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