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

Model Number	SP14MH30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found of the bur found the bur tang was not turning, which indicated the shaft was broken.The shaft measured 5.22¿ from tip to the break point.The break point corresponded to the proximal side of the outer tube radius, where the diameter of the shaft was 0.024¿.When viewed under magnification, the fracture contained circular patterns and the high points were worn down.The flutes at the tip had only minor wear; however, there was a buildup of biological contaminants just proximal to the cutting tip.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the bur tip was pulled out from the outer attachment at the cdor spine during a posterior spinal fusion procedure.The device was used for about a minute.The was a delay in the procedure.There was no patient impact.

• 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: 7852655
• Report Number: 1045254-2018-00416
• Device Sequence Number: 19310552
• Product Code: HBE
• UDI-Device Identifier: 00643169308428
• UDI-Public: 00643169308428
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: 05/22/2022
• Device Model Number: SP14MH30
• Device Catalogue Number: SP14MH30
• Device Lot Number: 0215520667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1