MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLADE 3.5 CURVED CONCAVE FULL RADIUS; SAW, POWERED, AND ACCESSORIES

Catalog Number 7210980

Device Problem Break (1069)

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

Event Date 03/18/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Evaluation was not possible, as the devices were not returned.Review of the device history records were performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Due to this fact we are unable to determine what may have caused the user to experience the reported incident.There are no indications that would suggest that the devices did not meet product specifications upon release into distribution.

Event Description

It was reported that the blade broke at the flexible port of the inner cannula during use.This occurred with 3 different blades over the course of two surgeries.The broken pieces were completely removed from the surgical site and the procedures were successfully completed using a back-up device.No patient injury or other complications were reported.Report 3 of 3.

• Brand Name: BLADE 3.5 CURVED CONCAVE FULL RADIUS
• 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: 5975646
• MDR Text Key: 55900806
• Report Number: 1219602-2016-01017
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 7210980
• Device Lot Number: 50705700
• Other Device ID Number: 1,440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2013
• 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