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

Model Number	SP12MH30
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that a device tip broke off in patient back.X-ray was taken and all pieces were retrieved.

• 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: 8803138
• Report Number: 1045254-2019-00347
• Device Sequence Number: 11436418
• Product Code: HBE
• UDI-Device Identifier: 00643169308497
• UDI-Public: 00643169308497
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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 Expiration Date: 01/21/2023
• Device Model Number: SP12MH30
• Device Catalogue Number: SP12MH30
• Device Lot Number: 0216977205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/18/2019
• 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: Other