MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200095

Device Problems Smoking (1585); Noise, Audible (3273)

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

Event Date 04/17/2019

Event Type  malfunction  

Event Description

It was reported that the blade made a noise and released smoke.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

One dyonics disposable 3.5mm incisor plus elite blade returned.The complaint stated: ¿the blade made a noise and released smoke.¿ the blade was found seized.Once the inner and outer were freed, wear bands and skiving was visible on the inner blade and inside the outer blade cup.Accumulated shavings were still attached which bound the blade.Drag was felt with rotation of the inner and outer blades.These symptoms were caused by distal pressure applied.As a result, binding, shavings and seizing occurred.No root cause related to the manufacture of the device was confirmed.

• Brand Name: INCISOR PLUS ELITE BLADE,3.5MM DSPL,DYO/
• 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: 8542065
• MDR Text Key: 142896362
• Report Number: 1219602-2019-00459
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010555694
• UDI-Public: 03596010555694
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: E527289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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