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	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery the suture cutter was dull and poor of sharpness.No delay and there was no back up available.Although no backup device is reported, there is no information that reasonably suggests a procedure cancellation, change in surgical technique nor use of competitor device occurred.No patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: one 72202589 suture cutter used for treatment, was not returned for evaluation.Due to product unavailability, investigation was limited.If further information becomes available, the complaint may be revisited.Instructions for use contains recommendations and precautionary statements for proper use of product.This reusable instrument includes recommendation for periodic maintenances.The consumable carbide components may become gritty causing friction.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 including binding and breakage.Complaint history review for the lot number reported indicated no similar allegations.Batch review did not indicate a condition, product or procedure failure that supported the allegation.There is no indication that product specifications were not met upon release to distribution.

• Brand Name: SUTURE CUTTER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 10037158
• Report Number: 1219602-2020-00748
• Device Sequence Number: 2986895
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 52650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1