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

Model Number	TN40RCD
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
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 that a the doctor removed the drill from holing sleeve on the side of the bed and the burr tip fell out during a transsphenoidal with navigation procedure.The device did not have contact with the patient.The procedure was completed with a backup device.There was no patient impact.
Additional Manufacturer Narrative
Analysis found out that there were abrasions in the inside diameter of the consistent with loading into a handpiece.Visually, the tip of the bur broke off at the shaft which would have resulted in the reported event.The portion that became detached measured 0.851¿ long.The break configuration showed circular patterns which is consistent with torsional stress.By design, the shaft diameter is nominally 0.0350¿ which decreases to 0.0240¿ / +-0.0005¿ in the area corresponding the outer tube bend for clearance purposes.The actual measurement of the diameter in area of the break was 0.0242¿ which is within specification.A review of the global complaint data showed no other complaints for this lot number.A pull test is performed during manufacturing which would have likely detected this issue.With no evidence to substantiate a manufacturing issue, the information most likely indicates inadvertent damage occurred as a result of a handling issue, such as activation of the bur while excess torsional loads were present.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: 9320427
• Report Number: 1045254-2019-00589
• Device Sequence Number: 2360306
• Product Code: ERL
• UDI-Device Identifier: 00613994776242
• UDI-Public: 00613994776242
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 02/09/2021
• Device Model Number: TN40RCD
• Device Catalogue Number: TN40RCD
• Device Lot Number: 0218309464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 80