MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO BLADE, RAD 60, 4MM, M4 ROTAT 5/BX; BUR, EAR, NOSE AND THROAT

Model Number 1884016HR

Device Problem Material Fragmentation (1261)

Patient Problem Hemostasis (1895)

Event Date 03/26/2014

Event Type  Injury  

Event Description

It was reported that while shaving the tissue from the ethmoid, the device exploded, leaving the broken tip inside the nasal cavity as he withdrew the faulty blade.No patient injury reported but it has caused unnecessary bleeding to the patient.The broken piece of blade was removed and a new blade was used to continue with the surgery.Meanwhile, the surgeon used a diathermy to stop bleeding before starting with the procedure again.There was no delay encountered.The patient is normal and has been discharged from hospital.

Manufacturer Narrative

Blank fields on this report are the result of information not being provided by initial reporter.This device is used for therapeutic purposes.Diathermy is the use of high frequency electric current to produce heat; used to either cut or destroy tissue or to produce coagulation.(b)(4).Product evaluation: upon analysis by our qe, the condition of the device showed customer use/handling based on the obvious damage observed on the returned sample.From visual evaluation, the spiral wrap of the middle shaft assembly was found hyperextended and broken near the tip with portion of it severely unraveled.The breakage of the spiral wrap assembly caused the tip to detach / separate.The blade teeth were observed under magnification and appeared to be free of damage.The spiral wrap hyperextension, breakage and unraveling is indicative of possible procedural / anatomical / operational factors encountered by the customer during procedure which may have led to the failure observed on the device.These factors include and are not limited to difficult anatomical location, hard bone/tissue structure.These factors can cause the customer to exert pressure, manipulate and/or maneuver the device in a manner that may lead to device breakage.There was no obvious indication of customer misuse / mishandling of the product or any manufacturing defect.(b)(4).

• Brand Name: BLADE, RAD 60, 4MM, M4 ROTAT 5/BX
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• 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: 3773552
• MDR Text Key: 4441331
• Report Number: 3004209178-2014-08116
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2014
• Device Model Number: 1884016HR
• Device Catalogue Number: 1884016HR
• Device Lot Number: H7661102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00045 YR
• Patient Weight: 85