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

Model Number 1884002

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2016

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: 2 un-sealed samples, part number 1884002, from lot number 0211682835 were received for analysis; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide] on both samples.When compared to the assembly drawing: visually, the tip of the inner cutter as broke off both samples.The portions that detached measured approximately 0.23 in length.When viewed under magnification, the inner cutters had fractured at the first proximal tooth valley.The deformation of the tips indicates the inner cutters impacted the outer tubes during rotation.This defect may occur if the blade was being used in the wrong direction (forward vs.Oscillate), ran over the recommended speed designated by labeled indications, or came in contact with an inappropriate material.The recommended operating speed is 5,000 rpm in oscillate mode / direction.The instructions for use indicate this blade is used for the resection of soft tissue or bone and warn, insertion of metal objects in blade or bur tip may cause the blade or bur to break.

Event Description

It was reported that during a maxillary sinusotomy, the surgeon proceeded to ask for the shaver and started using it by the interior ethmoid when, it just stop working.Initially we thought the blade was clogged, passed the brush through it and it was clear, so tried using it again with no luck.A replacement blade was requested.As we started attaching the other blade to the shaver we noticed that the patient was bleeding a little and started to suction when we noticed a metal tip.After inspecting the item we came to realize it was the tip of the inner blade of the shaver.After removing it from the patient's sinus he tried using the new tip that was placed on the shaver; as soon as that shaver began the same thing happened.The second tip landed outside the patient.There was no patient impact or injury.

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 north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6106356
• MDR Text Key: 60091274
• Report Number: 1045254-2016-00390
• 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: 10/21/2016

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: 1884002
• Device Catalogue Number: 1884002
• Device Lot Number: 0211682835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided; 04/03/2017
• Supplement Dates FDA Received: 04/03/2017; 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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: 73 YR