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

Model Number 72201513

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 05/15/2018

Event Type  malfunction  

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 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
• 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
• MDR Report Key: 7566008
• MDR Text Key: 110115620
• Report Number: 1219602-2018-00693
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010654458
• UDI-Public: (01)03596010654458(17)191019(10)50626600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• 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