MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CURVED LONG INCISOR PLUS ELITE BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72200494

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection confirmed the reported complaint.The device was dramatically bent.The inner blade had broken approximately 1.5 inches from the slough chamber.The condition of the device is the direct result of excessive side-loading during use.No root cause related to the manufacture of the device can be established.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the shaver blade broke in half during use.No patient injury or other complications were reported.The procedure was successfully completed using a back-up device.

• Brand Name: CURVED LONG INCISOR PLUS ELITE BLADE
• 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 ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5968454
• MDR Text Key: 55675141
• Report Number: 1219602-2016-00833
• Device Sequence Number: 1
• Product Code: HAB
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 72200494
• Device Lot Number: 50915681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2015
• 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