MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - IPC® M5 AND M4 30K; BUR, EAR, NOSE AND THROAT

Model Number	1884070RTD
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
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 healthcare professional (hcp) reported via a manufacturer representative that the device was separated and broke during a procedure.There was no patient impact.
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information from the healthcare professional (hcp) reported via a manufacturer representative that the device was broken but intact.The procedure was delayed for two minutes to obtain another bur.The case was completed with a new bur.
Additional Manufacturer Narrative
Analysis found that the inner hub was 0.19¿ away from its typical position when compared to the front hub.The inner proximal end of the inner assembly was still attached which indicates internal spiral wrap damage.There is a sleeve lining the inside diameter of the inner assembly.The liner was pushed out the proximal end by 0.50¿ which likely occurred due to the spiral wrap damage.The diamond grit cutting tip was compacted with biological contaminants which likely required the user to be more aggressive with the bur to maintain performance.The manufacturing instructions require checks for damage.There was no allegation of a defect prior to use.The information most likely indicates after the burs became compacted with contaminants, aggressive use caused friction, which eventually resulted in torsional overload breaking the inner assemblies.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - IPC® M5 AND M4 30K
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8286677
• Report Number: 1045254-2019-00043
• Device Sequence Number: 167901
• Product Code: EQJ
• UDI-Device Identifier: 00643169434646
• UDI-Public: 00643169434646
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2019

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 Model Number: 1884070RTD
• Device Catalogue Number: 1884070RTD
• Device Lot Number: 0216524471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 02/04/2019; 08/05/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 02/28/2019; 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60