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

Model Number 1884380EM

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the inner shafts broke 0.58¿ and 0.60¿ from the distal face of the inner hub which would have resulted in the reported malfunction.There were striations around the outside diameter of the break points indicating metal on metal contact during use.The break points correspond to the proximal end of the outer tube in the front hub.There was no damage to the distal tips.When viewed under magnification, there was deformation and indentations of the front hubs locking area consistent with aggressive use.There were no bends or signs of a concentricity issues.A review of the xpi did not indicate any evidence to point to improper manufacturing and there are checks for damage throughout the process.A review of the global complaint data showed no other complaints for this lot number; in contrast, this customer reported an issue with two from this lot in the same procedure.There was no allegation of a defect prior to use.The information indicates excess pressure was applied while in the handpiece during rotation which caused the deformation of the locking areas; which then caused the inner shafts and outer tubes to rub together until the inner shafts broke.There was no indication of device fragments and the breakages would have been contained by the outer tubes and the handpiece.There were no signs of heat deformation or discoloring.The ifu warns that excessive pressure applied to a bur/blade may cause a fracture.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported that the blade broke while engaging the ethmoid bone.Tried another and both blades broke when attempting the same engagement of ethmoid bone during the procedure for functional endoscopic sinus surgery (fess) with ethmoidectomy.The procedure was completed using back-up product.There were no fragments that remained inside the patient's body.There was no patient impact.Additional information received there are fragments and was returned with the blade for analysis.

• Brand Name: XPS® SYSTEM NAVIGATED 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 dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9389965
• MDR Text Key: 169298154
• Report Number: 1045254-2019-00640
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00643169209367
• UDI-Public: 00643169209367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2019

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: 07/21/2021
• Device Model Number: 1884380EM
• Device Catalogue Number: 1884380EM
• Device Lot Number: 0218135815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• 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: 32 YR