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

Model Number	1884068HS
Medical Device Problem Code	Break (1069)
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
Analysis results not available; devices not returned 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
It was reported that 3 burs broke during the same procedure, and each broke at the "beginning of normal use" when the drill was activated.There was no patient impact.
Additional Manufacturer Narrative
Date of this report: 12/22/2016.Description of event problem: additional information received confirms that after the beginning of use the devices broke in two and fell onto the patient.They were successfully removed; there was no patient impact or injury.Device available for evaluation? yes.Return date: 01/25/2017.Date manufacturer received: 01/24/2017.Product evaluation: 3 un-sealed samples, part number 1884068hs, from lot number 0210995705 were received for analysis.Visually, the inner shaft broke on all 3 samples which would have resulted in the reported event.The breaks showed striations around the outside diameters and occurred approximately 5/8¿ from the distal face of the inner hubs.This break is typical of excess pressure applied to the bur during use and indicates metal to metal contact with the proximal end of the outer tube.At the distal end there was gouging of the head support area on the inner and outer assemblies which is also consistent with excess pressure.In support of this, the gouging of the inside diameter of the outer tubes was primarily on the irrigation side which is the opposite side of where pressure would be applied during use.The outside diameter of the inner tube shall be 0.112¿ / +-0.001¿ and the samples measure between 0.111¿ and 0.1115¿ near the break which is within specification.The inside diameter of the outer tube shall be 0.153¿ / +-0.001¿ and the samples measure between 0.153¿ and 0.154¿ in the distal support area (not in the gouged area) which is within specification.(b)(4).Method: actual device evaluated.Results: friction problem; fracture problem.Conclusion: use error caused or contributed to event.
Event or Problem Description
Additional information received confirms that after the beginning of use, the devices broke in two and fell onto the patient.They were successfully removed; there was no patient impact or injury.
Additional Manufacturer Narrative
Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR - HIGH SPEED CURVED
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• MDR Report Key: 6260495
• Report Number: 1045254-2017-00030
• Device Sequence Number: 954789
• Product Code: EQJ
• UDI-Device Identifier: 20681490692919
• UDI-Public: 20681490692919
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 03/16/2024
• Device Model Number: 1884068HS
• Device Catalogue Number: 1884068HS
• Device Lot Number: 0210995705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: Not provided; 01/24/2017
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/16/2017; 09/28/2017
• Patient Sequence Number: 1