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

Model Number	TN30RCD
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that there was a residue consistent with biological contaminants on the device.Visually, the inner shaft broke.The break point corresponds to where the shaft diameter is reduced for the outer tube radius.The portion that became detached measure 2.305¿ from tip to break.The break itself contained circular patterns which indicates excess torsional loads.The diamond grit of the cutting head was compacted with biological contaminants.The reduced shaft diameter shall measure 0.0240 / +-0.0005¿ and measured 0.0241¿ indicating an in-specification condition.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 during a pituitary tumor procedure, the surgeon removed the drill bit from the patient and noticed that the tip had sheared off.All pieces were removed from the patient and they proceeded with the case using a different drill bit.There was no delay in the procedure.There was no patient impact or injury.
Additional Manufacturer Narrative
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: 8202543
• Report Number: 1045254-2018-00740
• Device Sequence Number: 1656798
• Product Code: ERL
• UDI-Device Identifier: 00613994776228
• UDI-Public: 00613994776228
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 09/19/2019
• Device Model Number: TN30RCD
• Device Catalogue Number: TN30RCD
• Device Lot Number: 0215163798
• 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: 12/04/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 122