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

Model Number	72201213
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7642100
• Report Number: 1219602-2018-00831
• Device Sequence Number: 1651706
• Product Code: NBH
• UDI-Device Identifier: 03596010591272
• UDI-Public: (01)03596010591272(10)50688160
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 10/09/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/01/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1