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

Model Number	1885061HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.Device evaluation anticipated but not yet begun.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 the bur broke at the base while in use.A replacement bur was used to complete the procedure.There was no patient impact.
Additional Manufacturer Narrative
Additional information was received indicating that the break did not result in fragments inside the patient.Reused single use device: no date mfr.Rec: jan/24/2017.One un-sealed sample of part number 1885061hs, from lot number 66542400 was received.The inner shaft was broken 0.16¿ from the distal face of the inner hub which would have resulted in the reported event.When viewed under magnification, there was damage to the hubs that is consistent with improper loading: dimples on the front hub prior to the locking area caused by the handpiece locking mechanism; and damage to the inner hub chevrons caused by the handpiece drive mechanism.The ifu has detailed instructions for properly loading a bur/blade into the handpiece.An improperly loaded blade would result in a lack of support and improper engagement with the handpiece.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.The customer was likely to experience the bur working at first, until the hub was worn down and subsequent shaft breakage.(b)(4).
Event or Problem Description
Additional information was received indicating that the break did not result in fragments inside the patient.
Additional Manufacturer Narrative
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: 6219190
• Report Number: 1045254-2017-00001
• Device Sequence Number: 16237712
• Product Code: EQJ
• UDI-Device Identifier: 20681490693060
• UDI-Public: 20681490693060
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2016

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: 03/01/2018
• Device Model Number: 1885061HS
• Device Catalogue Number: 1885061HS
• Device Lot Number: 66542400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Initial Date Received by Manufacturer: 12/09/2016
• Supplement Date Received by Manufacturer: Not provided; 01/24/2017
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/17/2017; 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1