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

Model Number	72200095
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the blade was activated, metal flakes shed from the inner blade.No patient injuries were reported.
Additional Manufacturer Narrative
The outer diameter of the inner blade surface has wear damage.This surface condition indicates pressure/force was applied to the device.Metal shavings can result from excessive ¿side-loading¿ on the blade during use.There is drag felt with rotation of the inner and outer blade.This is a symptom of damage caused by this pressure as well.As a result, binding, shavings and seizing can occur.No root cause related to the manufacture of the device can be established.Use error may have been a contributing factor for this event.

• 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: 6799364
• Report Number: 1219602-2017-00935
• Device Sequence Number: 13732044
• Product Code: HAB
• UDI-Device Identifier: 03596010555694
• UDI-Public: (01)03596010555694(17)220323(10)50654672
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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 Expiration Date: 03/23/2022
• Device Model Number: 72200095
• Device Catalogue Number: 72200095
• Device Lot Number: 50654672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1