MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM FULL RADIUS PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203521

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/30/2019

Event Type  malfunction  

Event Description

It was reported that, during a chondroplastic surgery, the 4.5 mm full radius platinum blade left an oil-like residue in the femoral condyle.The substance was not removed from the body.A new device was used to complete the procedure.The surgery was not delayed.The patient was not injured.

Manufacturer Narrative

The reported 4.5mm full radius platinum series blade, intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the blade leaked an oily substance during use onto the patients condyle.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive silicone lubricant applied during manufacture.The oily 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.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Adverse event or product problem: response added to this question.Event reported is a product problem.

• Brand Name: 4.5MM FULL RADIUS PLATINUM SERIES
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8900936
• MDR Text Key: 154556533
• Report Number: 1219602-2019-00974
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554024333
• UDI-Public: 00885554024333
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2024
• Device Catalogue Number: 72203521
• Device Lot Number: 50787198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1