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

Model Number	1885076HSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 1885076hse from lot number 0212876711 was received.There was a residue consistent with biological contaminants on the device.A microscope and calipers were used to evaluate the device.The inner shaft broke 0.145¿ from the distal face of the inner hub which would have resulted in the reported malfunction.When viewed under magnification, there was damage to the hubs that is consistent with improper loading: dimples on the front hub prior to the locking area caused by the handpiece locking mechanism and locking area damage caused by the back side of the front collet of the handpiece.The ifu has detailed instructions for properly loading a bur/blade into the handpiece.There were no loose components.There was no allegation of damage prior to use.Improperly loading a blade into a handpiece would result in the reported complaint.
Event or Problem Description
The sales rep reported that the bur broke a few minutes after it was connected to the handpiece.The break did not result in a fragment(s).There was no patient injury and no delay to the surgery.
Additional Manufacturer Narrative
Corrected information: sex.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: 6666876
• Report Number: 1045254-2017-00206
• Device Sequence Number: 16161069
• Product Code: EQJ
• UDI-Device Identifier: 00613994233196
• UDI-Public: 00613994233196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: 02/26/2021
• Device Model Number: 1885076HSE
• Device Catalogue Number: 1885076HSE
• Device Lot Number: 0212876711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1