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

Model Number 1884016HRE

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 07/07/2014

Event Type  malfunction  

Event Description

A sales rep reported that three blades failed during a case while he was present.The sales rep stated that all three blades worked correctly at first, then stopped rotating.On the first blade, the blade mechanism along with the springs and the coils retracted distally (popped forward out of the cannula) but did not detach from the blade; it was still connected.On all three blades the function that allows the blade to rotate would stop.They did not have any more of that product after the three blades failed.The surgeon had to use a 40 degree angle blade to get inside the sinus (typically requires a 60 degree angle blade).Analysis indicated that the tip of one of the blades was detached/missing.There was no reported patient impact and they were able to complete the procedure.Follow-up with the sales rep, who spoke with the physician, indicated that the physician is confident that the blade tip was not left in the patient during the surgery, and is not recommending an mri or x-ray to confirm.The physician reported that the patient is recovering as expected and has not experienced any complications.

Manufacturer Narrative

(b)(4).The three blades were returned for analysis.The product analysis indicates that sample a tip was not attached and not returned; sample b would index but it would not move the tip; sample c would index; however, it was binding.There was no evidence of improper loading, excess pressure applied while in use, and no physical damage to indicate misuse/mishandling.Therefore, misuse and mishandling have been ruled out as a potential cause.The information provided indicates interference occurred between the inner/middle assembly and the outer sheath at the apex of the bend, which may have taken place during manufacturing/production.Result: stress problem.Conclusion: manufacturing deficiency.This device is used for therapeutic purposes.

Manufacturer Narrative

Follow-up from the customer was received indicating that the patient had plain x-rays of the sinuses showing no metallic foreign body.

Event Description

Follow-up from the customer indicates that the patient had plain x-rays of the sinuses showing no metallic foreign body.

• Brand Name: RAD® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 3973441
• MDR Text Key: 18292914
• Report Number: 1045254-2014-00162
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/18/2014

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 Expiration Date: 12/11/2017
• Device Model Number: 1884016HRE
• Device Catalogue Number: 1884016HRE
• Device Lot Number: 0207831388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00056 YR