MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1882940HR

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

This device is used for therapeutic purposes.No consequences or impact to patient (b)(4); material fragmentation (b)(4).Product evaluation: analysis found that when viewed under magnification it was observed that the tip of the inner tube had broken off at the proximal edge of the mouth opening, leaving jagged, irregular edges and measured approximately 5mm in length.There was gouging on the detached portion of the blade, and small striations on the inside of the outer tube which indicates metal to metal contact, and possibly excess pressure.A stylette was used to remove an obstruction from the inner tube which was found to be a bony fragment.The presence of the obstruction located directly behind the break location most likely indicates that the procedure was halted shortly after the tip broke off and that the contact with bone may have attributed to the fragmenting.Note: the inferior turbinate blade is designed to be used in close proximity to bony structures within the nasal cavity.The instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture; however, the level of gouging and striation present on and in the inner and outer tubes does not clearly indicate that excess force was applied, though it cannot be ruled out.

Event Description

It was reported that ¿while a turbinate blade was being used in a patient the tip broke off.The pieces were retrieved and the patient is fine; they switched out the blade and were able to complete the case.¿.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 5271956
• MDR Text Key: 33047188
• Report Number: 3004209178-2015-23921
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2015

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: 05/16/2019
• Device Model Number: 1882940HR
• Device Catalogue Number: 1882940HR
• Device Lot Number: HG0JWN3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2015
• 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
• Patient Age: 00040 YR