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

Model Number	1883673HS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates that one opened sample of part number 1883673hs from lot number 0211842637 was received.A microscope and calipers were used to analyze the device.When viewed under magnification, there was gouging of the outside diameter of the inner shaft just proximal to the tip with corresponding damage to the outer tube support area.The inner shaft broke 0.65¿ from the distal face of the inner hub with striations around the outside diameter of the break point indicating metal on metal contact.The break point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there was no deformation of hubs, no ¿melting¿.The front hub high point measured 0.372¿, required is 0.372¿ +0.002 / -0.003 which is in specification.The inner hub outside diameter requirement is 0.330¿ / +-0.002¿ and measures from 0.329¿ to 0.332¿ which is in specification.There was no allegation of a defect prior to use.The information indicates excess pressure was applied during use which caused the distal end wear and shaft breakage.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the bur stopped during surgery (fess).The doctor uninstalled the bur and reported the base (hub) had "melted".A replacement bur was used to complete the surgery.There was no patient injury.The product analysis indicates there was no evidence of the hub melting, but the bur shaft was broken.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the customer indicates the bur was being used at a high speed with the m4 microdebrider handpiece.

• 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: 7045763
• Report Number: 1045254-2017-00418
• Device Sequence Number: 126301
• Product Code: EQJ
• UDI-Device Identifier: 20721902686201
• UDI-Public: 20721902686201
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2018

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: 08/21/2024
• Device Model Number: 1883673HS
• Device Catalogue Number: 1883673HS
• Device Lot Number: 0211842637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1