MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® CLEARVIEW - LEGEND TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	SD12MH30D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis indicates one opened sample of part number (b)(4), from lot number [no information] was received for analysis.Visually, the distal tip of the bur was broken off at the shaft just behind the head which would have resulted in the reported event.The portion that became detached measured 0.175¿ long.The break point contained circular patterns indicating excess torsional loads as well as a configuration of sheer / bending stress.There were tool marks on opposing sides distal to the break and tool marks on opposing sides proximal to the break which likely contributed to the breakage.There were contaminants compacted into the diamond grit; this would have resulted in excess pressure to be applied by the user to maintain performance which in turn would generate excess torsional load.The information most likely indicates excess pressure during use resulted in the observed break.Bending or prying of the tip with the use of another tool may have also contributed to the breakage.There was an out of specification condition identified as it relates to the complaint.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a micro endoscopic discectomy (med) procedure, the bur was broken.There was no patient impact.There were no broken pieces r emaining inside the patient's body.

• Brand Name: XPS® CLEARVIEW - LEGEND TOOL
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7779402
• Report Number: 1045254-2018-00371
• Device Sequence Number: 1319381
• Product Code: HBE
• UDI-Device Identifier: 00643169308329
• UDI-Public: 00643169308329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081277
• 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
• Report Date (Section B): 08/13/2018

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 Model Number: SD12MH30D
• Device Catalogue Number: SD12MH30D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1