MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203013

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

It was reported that, during a knee arthroscopy, the blade leaked a substance similar to grease that left a residue on the patient tissue.It was not possible to remove such residue.A back-up device was available to complete the procedure without delay.The patient has not been stated to be injured.

Manufacturer Narrative

One 72203013 4.5mm incisor plus platinum blade used for treatment, was not returned for evaluation.The complaint stated: ¿the blade leaked a substance similar to grease that left a residue on the patient tissue¿.Due to product unavailability, physical evaluation, full investigation and conclusions were not possible.Factors affecting device performance include: device ability, surgical ability and surgical site preparation according to instructions for use.Instructions for use confirms instructions, recommendations and precautionary statements and for proper use of product.To produce a device with less friction, silicone is used along with a silver plating process for additional lubrication between inner and outer blades.The silver plate surface may become discolored from silver tarnish.It has been determined that the excess silicone located at the bottom of the blade tip, or the appearance of discoloration will not impact the patient or end user.Platinum improves lubricity and allows for reduced frictional contact between the stainless steel inner and outer blades.It also discolors when exposed to certain elements.The red substance that's occasionally found on our blades and peaks curiosity of our customers is actually a silicone lubricant from the manufacturing process.Testing has confirmed that the silicone lubricant is biocompatible, non-toxic, non-irritating and non-sensitizing.The silicone and silver improves performance of the device and has been determined to have no adverse effect on patient safety.This observation is monitored through surveillance.Complaint history lot review found other complaints of this nature.Product met specifications upon release to distribution.

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8697752
• MDR Text Key: 147953296
• Report Number: 1219602-2019-00700
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1