MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - STYLUS TRANSNASAL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	TN40RFL
Medical Device Problem Codes	Material Separation (1562); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
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 a manufacturer representative that two (2) burs failed during a microdissectomy procedure.The device was connected to the handpiece, tested and was not turning.The bur was detached from the unit where it should be a sealed unit from manufacturing which means both burs should not be able to pull out.The hcp noted that the devices did not break and the burs were prepared correctly according to the directions given in the product manual.The hcp confirmed that it was the initial use of the devices and there was no troubleshooting possible as both are disposable devices.There was a delay in the procedure due to opening of the second bur and changing of attachment.A back-up device was used to complete the procedure.There was no patient impact or injury.
Additional Manufacturer Narrative
For analysis of the device, the shafts were turned by hand using the head of the bur while viewing the drive mechanism [the bur tang]; the tangs were not turning which indicates a broken shaft.The shafts were removed from the assemblies for further analysis [they both measured 5.70¿ from tip to break point].The break points at the proximal end corresponds to the distal side of the tack weld on the tang.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - STYLUS TRANSNASAL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8077880
• Report Number: 1045254-2018-00604
• Device Sequence Number: 11144929
• Product Code: ERL
• UDI-Device Identifier: 00613994776259
• UDI-Public: 00613994776259
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K081277
• 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): 12/22/2018

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: 04/10/2019
• Device Model Number: TN40RFL
• Device Catalogue Number: TN40RFL
• Device Lot Number: 0214218680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90