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

Model Number	1884068HS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned sample didn't contain the distal most potion of the tip and spiral wrap as reported.Visually, the spiral wrap broke which would have resulted in the reported event.The break location corresponds to the distal end of the outer tube.The spiral wrap was twisted in on itself in a clockwise direction which indicates excess torsional loads.The inner shaft was worn 0.61¿ from the distal face of the inner hub which is an indication of aggressive use.The wear corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification; there was deformation and indentations of the front hub locking area; there was wear and gouging of the inside diameter of the distal end of the outer tube; both are consistent with aggressive use.There was no allegation of a defect prior to use.The information indicates excess pressure was applied during use which caused the deformation of the hub locking area; which resulted in the assemblies rubbing together causing wear and excess torsional loads through friction.The ifu warns that excessive pressure applied to a bur/blade may cause a fracture.There was an out of specification condition identified as it relates to the complaint (due to physical damage).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via manufacturer representative that a bur broke intra-operatively.Bur was replaced to complete the procedure.There was no patient impact.On follow up, it was confirmed through a post-operative ct that there were no fragments left in the patient¿s body.

• Brand Name: XPS® BUR - HIGH SPEED CURVED
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7849290
• Report Number: 1045254-2018-00410
• Device Sequence Number: 1468728
• Product Code: EQJ
• UDI-Device Identifier: 00681490692915
• UDI-Public: 00681490692915
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1884068HS
• Device Catalogue Number: 1884068HS
• Device Lot Number: 0214929781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention