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

Model Number	1884380EM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9389965
• Report Number: 1045254-2019-00640
• Device Sequence Number: 1763020
• Product Code: EQJ
• UDI-Device Identifier: 00643169209367
• UDI-Public: 00643169209367
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR