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

Model Number	1883070HS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: analysis results not available, device not received for evaluation.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
The facility reported that during a fess, the "frontal burr suddenly broke and the tip ejected during the operation (not in the patient).Tip flew near anesthetic machine." there was no patient impact.
Additional Manufacturer Narrative
Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product evaluation: 1 opened sample, part number 1883070hs, from lot number 0211531825, was received for analysis.There was a residue consistent with biological contaminants on the device.Visually, the tip was broken off which would have resulted in the reported event.The length of the detached component from tip to break was approximately 1¿, breaking at the distal end of the spiral wrap.There was gouging and thinning of the distal end of the outer tube wall which is an indication of aggressive use.There was corresponding gouging just proximal to the tip.The information most likely indicates that aggressive use such as bending or prying resulted in torsional overload which cause the break.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED RAD®
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6623387
• Report Number: 1045254-2017-00178
• Device Sequence Number: 788578
• Product Code: EQJ
• UDI-Device Identifier: 20681490464608
• UDI-Public: 20681490464608
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2017

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: 06/27/2024
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0211531825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017; 10/23/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 09/07/2017; 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1