MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR PLUS,ELITE, POWER-MINI DISP 2.9; SAW, POWERED, AND ACCESSORIES

Model Number	72201513
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 2.9 incisor plus power-mini blade was returned for evaluation.Visual assessment confirmed the reported breakage.The inner blade tip has broken off distal to the weldment.The weldment is intact.The inner blade also shows heavy debridement at the break area.The outer shaft is bent.The condition of the device indicates excessive side-loading was applied during 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.No further investigation is warranted at this time.
Event or Problem Description
It was reported that a piece of the blade broke off in the patient.All pieces were removed.There was no delay or patient injury reported.

• Brand Name: INCISOR PLUS,ELITE, POWER-MINI DISP 2.9
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7566008
• Report Number: 1219602-2018-00693
• Device Sequence Number: 19381769
• Product Code: HAB
• UDI-Device Identifier: 03596010654458
• UDI-Public: (01)03596010654458(17)191019(10)50626600
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: 10/19/2019
• Device Model Number: 72201513
• Device Catalogue Number: 72201513
• Device Lot Number: 50626600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1