MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTURE CUTTER; ACCESSORIES,ARTHROSCOPIC

Model Number 72202589

Device Problem Failure to Cut (2587)

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

Event Date 06/11/2020

Event Type  malfunction  

Event Description

It was reported that during a cl reconstruction surgery the suture cutter did not cut the suture.No patient injuries or significant delay was reported.Surgery was completed using a smith and nephew back-up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: one suture cutter used in treatment, was returned for evaluation.The complaint states: ¿during a cl reconstruction surgery the suture cutter did not cut the suture¿.Device was functionally tested and confirms complaint.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper use of device or proper cleaning.The instructions for use sates: ¿pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.Further investigation is not warranted at this time.

• Brand Name: SUTURE CUTTER
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10244444
• MDR Text Key: 197947833
• Report Number: 1219602-2020-00997
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010652447
• UDI-Public: 03596010652447
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

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 Model Number: 72202589
• Device Catalogue Number: 72202589
• Device Lot Number: 46735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1