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

Catalog Number	72200095
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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/
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8542065
• Report Number: 1219602-2019-00459
• Device Sequence Number: 10854652
• Product Code: HAB
• UDI-Device Identifier: 03596010555694
• UDI-Public: 03596010555694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: E527289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72200095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1