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	10/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the knot pusher cut the suture while knotting it.A back-up device was available and there was no delay during surgery.No patient injury reported.
Additional Manufacturer Narrative
Device 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 #: (b)(4) and two strands of #2 ultrabraid suture.The device did not damage the suture in any manner.This investigation could not verify any evidence of product contribution to the reported problem.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Complaint history search revealed no additional complaints for this production lot.

• 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: 6931095
• Report Number: 1219602-2017-01276
• Device Sequence Number: 16368296
• Product Code: NBH
• UDI-Device Identifier: 03596010591272
• UDI-Public: (01)03596010591272(10)50652645
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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: 50652645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Initial Date Received by Manufacturer: 10/08/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 80