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

Model Number	1883070HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.A product analysis has not been performed.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 sales representative reported that the doctor was inserting a high speed rad frontal finesse bur into an m4 handpiece when the doctor pulled on the front and a piece (tip and spiral wrap) of the bur became loose.The bur was immediately taken out the m4 handpiece and other burs were used to complete the procedure.
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 1883070hs from lot number 0210526037 was received.A microscope and calipers were used to evaluate the device.Visually, the inner spiral wrap was stretched which resulted in the tip extending beyond the support area of the outer tube and would have resulted in the reported event.Although there was damage to the spiral wrap, the remainder of the inner assembly spun freely by hand.There was gouging and a thinning of the distal outer tube wall thickness which is indicative of excess pressure applied to the bur while in use.There are inspections for damage throughout the manufacturing process.There was no allegation of a defect prior to loading the device in the handpiece and / use.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates that aggressive use resulted in the gouging and wear which increased the torsional load and caused the spiral wrap damage (this may have been exacerbated by pulling on the front / tip as indicated by the customer).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 n; jacksonville FL 32216
• MDR Report Key: 6825120
• Report Number: 1045254-2017-00295
• Device Sequence Number: 10981192
• Product Code: EQJ
• UDI-Device Identifier: 20681490464608
• UDI-Public: 20681490464608
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 11/21/2017

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: 12/02/2023
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0210526037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1