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

Model Number 1884005

Device Problem Material Fragmentation (1261)

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

Event Date 11/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for evaluation.

Event Description

It was reported during an endoscopic sinus surgery,while using the silver bullet blade, it broke off mid use inside the patient.Follow-up with the customer reported the doctor noticed the tip of the blade broke off mid-use.The broken piece was retrieved from the patient.There was no patient impact or injury.

Manufacturer Narrative

Device returned to manufacturer: 01/11/2016.The device was received for product analysis.Condition upon receipt: 1 un-sealed sample, part number 1884005, from lot number 0 209773942 received; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings), calipers.Evaluation: when compared to the assembly drawing, visually the tip of the inner blade was broke off which would have resulted in the reported event.The tip was returned and measured 0.22¿ long.The break point corresponds to the first proximal valley of the inner blade tooth.When viewed under magnification, there was damage to the hubs that is consistent with improper loading - dimples on the front hub prior to the locking area caused by the handpiece locking mechanism; locking area damage caused by the back side of the front collet of the handpiece; and damage to the inner hub chevrons caused by the handpiece drive mechanism.The instructions for use has detailed instructions for properly loading a bur/blade into the handpiece.The improperly loaded blade may have contributed to the malfunction.The deformation of the break is consistent with the inner tip contacting the outer tip during use.For this break to occur, the tip would have to be deformed or become deformed and / or come in contact with an unapproved material.The most probable cause of the event is related to operational context.Method ¿ actual device evaluated; labeling evaluation; microscopic inspection.Results ¿ deformation problem; fracture problem.Conclusion ¿ operational context caused or contributed to event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® 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, INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint dr n; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 5267426
• MDR Text Key: 32894343
• Report Number: 1045254-2015-00410
• 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,Followup,Followup
• Report Date: 11/11/2015

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: 06/23/2023
• Device Model Number: 1884005
• Device Catalogue Number: 1884005
• Device Lot Number: 0209773942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided; 01/12/2016
• Supplement Dates FDA Received: 01/12/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2015
• 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: 00075 YR
• Patient Weight: 65