MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW; SAW, POWERED, AND ACCESSORIES

Catalog Number 7210976

Device Problem Break (1069)

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

Event Date 11/27/2018

Event Type  malfunction  

Event Description

It was reported that during the procedure, the shaver blade tip got broken during procedure.It is unknown if there was delay or back up available.No patient injury was reported.

Manufacturer Narrative

One (b)(4) disposable 4.5mm incisor plus elite blade reported on.This product is sold as a box of six-pack.They are not intended to be sold individually.The product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.This blade has a maximum rotational speed of 5000rpm vs.Other popular blade products that have speeds of up to 10,000rpm.Tip breakage may be due to inadvertent pressure applied while deburring which causes wear bands on the inner blade surface.Per the devices instructions for use ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.Final product met predetermined specifications upon release to distribution.Updated.

Event Description

It was reported that during the procedure, the shaver blade tip got broken.It is unknown if there was delay or back up available.No patient injury was reported.

• Brand Name: INCISOR PLUS ELITE BL,4.5MM,DSPL,DYO PW
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8235475
• MDR Text Key: 132913648
• Report Number: 1219602-2019-00051
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010532626
• UDI-Public: 03596010532626
• Combination Product (y/n): N
• Reporter Country Code: NP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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: 06/09/2021
• Device Catalogue Number: 7210976
• Device Lot Number: 50605443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 02/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1