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

Catalog Number 72203013

Device Problem Dull, Blunt (2407)

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

Event Date 08/21/2019

Event Type  malfunction  

Event Description

It was reported that a blade was found un-sharp and losing particle during use.A backup device was used to complete the surgery.No significant delay or patient injury reported.

Manufacturer Narrative

One 72203013 incisor plus platinum 4.5 mm blade used for treatment, was returned for evaluation.(device #2 will not be returned per analyst.) the complaint stated: ¿blade was found un-sharp and losing particle during use.¿ the teeth showed no abnormality and were quite sharp.Product was tested and performed as expected.There were no unusual observations.The blade connected, ran in forward, reverse and oscillating.It switched between modes with no issue.There were no error messages indicated on the control panel.The sluff chamber, both blades and tips had no outstanding observations.The inner edgeform blade was then grasped between, rotated and wiped on paper.Two light tracks of fine grey particulate remained on the paper.The faint, light-grey substance identified in the initial evaluation after forcibly wiping the inner edgeform is attributed to the silicone fluid which the inner assembly is dipped in during the manufacturing process to improve lubricity and reduce shedding when using the finished device.Under standard conditions for use per the instructions for use, there were no abnormalities.The symptom observed is consistent with the effects warned against in the instructions for use when the device instructions are not followed.Based upon the conditions required to recreate the issue, there is evidence to support that the user had applied excessive side-loading forces and/or ran the device without sufficient irrigation.Note that, based upon the components of the device, this residue would be composed of the silicone fluid, the tin-nickel plating, and/or the base metal used in the device.Biocompatibility report notes these components (304 stainless steel tips with 17-4 hardened tips, tin-nickel plating, and silicone dipping) and concluded that the device is safe and compatible with biological systems.

• 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: 9073043
• MDR Text Key: 158774161
• Report Number: 1219602-2019-01127
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• 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: 72203013
• Device Lot Number: 50787193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1