MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP; SAW, POWERED, AND ACCESSORIES

Catalog Number 7205305

Device Problem Material Discolored (1170)

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

Event Date 06/03/2019

Event Type  malfunction  

Event Description

It was reported that during a knee procedure, it was noticed that the tip of the blade was black.There was no delay or patient injuries but, it is unknown how the procedure was finished since no backup device was available to complete it.Attempts were made to retrieve further details about the event but the complainant does not have more information.

Manufacturer Narrative

One 7205305 3.5mm full radius disposable blade used for treatment, was not returned for evaluation.A customer photo was provided.The device appeared in good condition.Silicone is used in during manufacturing along with a silver plating process.The silver plate surface may become discolored.Visual inspection indicated evidence of silicone and silver tarnish discoloration.To produce a device with less friction, silicone is used for additional lubrication between inner and outer blades.This may encourage subsequent tarnish of the silver.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.¿surillium is the proprietary, silver coating that 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 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 one other complaint for this lot.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: FULL RADIUS BLADE,3.5MM,DISP
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8726465
• MDR Text Key: 148947245
• Report Number: 1219602-2019-00739
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010251343
• UDI-Public: 03596010251343
• 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: 07/22/2019

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 Expiration Date: 05/03/2023
• Device Catalogue Number: 7205305
• Device Lot Number: 50731902
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR