MAUDE Adverse Event Report: MEDTRONIC XOMED INC. RAD® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1884012EM

Device Problems Material Fragmentation (1261); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

It was reported that ¿a trackable rad 12 blade fell apart during a procedure.The end of the blade separated from the barrel.¿ it was reported that there was some clogging within the blade and the user ¿was repeatedly cleaning it with a stylet¿.Another blade was used to complete the procedure.There was no patient impact.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: analysis found that there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].When compared to the assembly drawing: the tip of the outer blade broke off at the first coil of the spiral wrap which would have resulted in the reported malfunction.The portion that became detached measured 0.45¿.The inner blade would spin and middle blade would index freely by hand.When viewed under magnification, there was damage to the hub that is consistent with improper loading; dimples on the front hub prior to the locking area caused by the handpiece locking mechanism.When viewed under magnification, there was deformation of the locking area on the front hub which indicates that at some point the blade was loaded properly and that excess pressure was applied to the blade.It was reported there was some clogging and the blade was repeatedly cleaned with a stylette which reportedly was the likely cause for the failure.There was some minor damage to the tips of the inner and outer blade tips which was likely caused by the repeated cleaning's.Method: microscopic inspection.Results: fracture problem.

Manufacturer Narrative

(b)(4).

• Brand Name: RAD® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 3927288
• MDR Text Key: 21730146
• Report Number: 1045254-2014-00148
• Device Sequence Number: 1
• Product Code: EQJ
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

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 Model Number: 1884012EM
• Device Catalogue Number: 1884012EM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00051 YR
• Patient Weight: 78