MAUDE Adverse Event Report: MEDTRONIC, INC. MIDAS REX LEGEND; BONE MILL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/16/2014

Event Type  malfunction  

Event Description

Bone mill did not mill, unable to grind the bone fine enough to proceed with procedure.

• Brand Name: MIDAS REX LEGEND
• Type of Device: BONE MILL
• Manufacturer (Section D): MEDTRONIC, INC.; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 4131323
• MDR Text Key: 4923103
• Report Number: 4131323
• Device Sequence Number: 1
• Product Code: LYS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 98