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

Model Number	72202589
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during checking before using the device, the suture cutter had been dull and poor of sharpness.No delay and it is unknown how the procedure was completed.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 72202589 suture cutter was not used for treatment but was returned for evaluation.This is a reusable instrument.The handle grip motion opens and closes but sticking was observed.The carbide cutter inserts are in place.These consumable carbide components may become gritty causing friction with each other or the device.There is no gritty feeling.The cutters cut 4 strands of suture cleanly with no hesitation or fraying.Instructions for use covers cleaning methods and discusses care with removable components.Demineralized water may help avoid mineral deposits.Antimicrobial lubricant soaks aid with the movement freeing of stiffened instrument parts.Dulled cutters are subject to malfunction and breakage.Complaint history review indicated no similar no allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Product met specifications upon release to distribution.No root cause related to the manufacture of this device was confirmed.

• Brand Name: SUTURE CUTTER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10446062
• Report Number: 1219602-2020-01306
• Device Sequence Number: 17147809
• Product Code: NBH
• UDI-Device Identifier: 03596010652447
• UDI-Public: 03596010652447
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 72202589
• Device Catalogue Number: 72202589
• Device Lot Number: 55560
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1