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

Model Number	31181098E
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation was not performed; product was not returned for analysis.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while the doctor was drilling the cochlea with this 1.0mm bur, the distal part of the bur (the head, the metal part) broke away from the shaft.The doctor recovered this part from the surgical field with forceps.There was no patient injury.
Additional Manufacturer Narrative
One un-sealed sample of part number 31181098e and lot number 0211715410 was received.There were trace residues consistent with biological contaminants on the device.Visually, the tip was broke off which would have resulted in the reported event.The tip was not returned.The inner shaft assembly was removed for further analysis.There were unusual abrasions around the shaft circumference 0.01¿, 0.02¿, 0.08¿, 0.12¿, 0.13¿, and 0.14¿ proximal to the break.The customer indicated the device broke while drilling.There was no indication of an issue prior to use.The drawing indicates the assembly is subjected to a 10lbf pull force while supported by the housing; this would have likely detected any anomaly in the construction of the device or any defect related to the tip / shaft strength.The damage to the shaft and tip most likely indicates the tip broke as the result of excess forces during use.Note ¿ excess; exceeded sufficient pressure required for operation.The ifu warns excessive pressure applied to bur may cause bur fracture.
Event or Problem Description
Additional information was received indicating that the surgery was completed with another visao bur (product # 31181098e).
Additional Manufacturer Narrative
Corrected information: sex, no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6251273
• Report Number: 1045254-2017-00028
• Device Sequence Number: 16332632
• Product Code: EQJ
• UDI-Device Identifier: 00885074322216
• UDI-Public: 00885074322216
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 12/22/2016

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: 07/31/2020
• Device Model Number: 31181098E
• Device Catalogue Number: 31181098E
• Device Lot Number: 0211715410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided; 02/06/2017
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 02/24/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 20