MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - HIGH SPEED CURVED; BUR, EAR, NOSE AND THROAT

Model Number	1884068HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via distributor that the two blades got broken immediately after into use during the functional endoscopic sinus surgery.The two blades were used in one operation and it was the initial use for both blades.The blade was used to drill the bone.The blade was broken but not detached.There was no error code shown on the power console.There was no fragments left inside the patient's body.The case was completed using the third new blade.There was a less than 5 minutes delay in the procedure; however, there was no adverse effect or patient impact.There was no patient impact.
Additional Manufacturer Narrative
Analysis of the device found that there was a residue consistent with biological contaminants.The inner shafts broke 0.69¿ and 0.11¿ from the distal face of the inner hub.There were striations around the outside diameter of the break points.The break points correspond to the proximal end of the outer tube in the front hub and front hub bushing.There was no damage to the distal tips.When viewed under magnification, there was deformation and indentations of the front hubs locking area.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED CURVED
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8054752
• Report Number: 1045254-2018-00578
• Device Sequence Number: 1706323
• Product Code: EQJ
• UDI-Device Identifier: 00681490692915
• UDI-Public: 00681490692915
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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: 05/05/2023
• Device Model Number: 1884068HS
• Device Catalogue Number: 1884068HS
• Device Lot Number: 0209577425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1