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 Date 05/24/2019

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 4.5mm incisor plus platinum blade was returned for evaluation.Visual assessment of the returned blade showed tarnish on the inner blade.The blades were visually inspected using a stereo microscope and no residue was observed.The inner and outer blade surfaces were wiped and no grease like residue was observed.Plating is a s&n process used at the time of manufacture, which helps prevent shedding.It 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 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.During the manufacturing process, we coat our inner shaver blades in a silicone bath to provide additional lubrication between the blades when used during the surgical procedure.Occasionally, when applying the silicone lubricant, some of it may pool within the shaver blade and, after some time, forms an area of red substance.Without photos of the affected tissue, the root cause could not be definitively concluded; however, it is highly likely that the reported residue was the biocompatible silicone lubricant applied during manufacturing.No patient impact is anticipated from the reported events.Should clinically relevant documentation become available, the medical investigation may be re-evaluated.

• 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: 8684803
• MDR Text Key: 147520758
• Report Number: 1219602-2019-00666
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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: 50779836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Date Manufacturer Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1