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

Model Number	1882960
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
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 a manufacturer representative that the tip of two (2) burs broke off during the procedure.There was no delay to the procedure as a result of this event.It was noted that there was no broken piece(s) that was left inside the patient's body.There was no patient impact or injury.On follow-up, it was reported by the manufacturer representative that the tip broke off most likely due to the use of too many rpm; the maximum for the bur is 6.000 rpm and the handpiece or console can go up to 30.000 rpm.The customer was not able to check the rpm that was being used.
Additional Manufacturer Narrative
Analysis found that the tips of the burs broke off at the proximal end of the suction window which would have resulted in the reported event.The portions that detached measured 0.408¿ and 0.402¿ respectively.The irrigation hoods at the distal tips were ground down.The inner and front hub bushings were dislodged from their seated position.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® 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: 8784946
• Report Number: 1045254-2019-00331
• Device Sequence Number: 13870079
• Product Code: EQJ
• UDI-Device Identifier: 20681490047283
• UDI-Public: 20681490047283
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 11/23/2022
• Device Model Number: 1882960
• Device Catalogue Number: 1882960
• Device Lot Number: 0208998962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1