MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS, 2.9, MAG-MINI, DISP. BLA; SAW, POWERED, AND ACCESSORIES

Catalog Number 72201509

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

One 2.9 full radius mag-mini blade was returned for evaluation.Visual assessment confirmed nothing to be broken.The outer blade is bent.The inner blade shows metal debridement at the distal tip.Dimensional assessment of the device found it to meet print specifications.All indications point to excessive side-loading during use which likely caused the blade to bend resulting in a misalignment and the observed debridement.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 blade broke during use.The broken piece was removed from the surgical site using graspers and the procedure was successfully completed using a back-up device.No patient injury or other complications were reported.

• Brand Name: FULL RADIUS, 2.9, MAG-MINI, DISP. BLA
• 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: 5969084
• MDR Text Key: 55327491
• Report Number: 1219602-2016-00836
• 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: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 72201509
• Device Lot Number: 50920601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2015
• 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