MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX DISSECTING TOOL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number T12MH25L

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

The dissecting tool broke in two while using.Both of the pieces were retrieved and there was no injury to the patient.

• Brand Name: MIDAS REX DISSECTING TOOL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street; fort worth TX 76137
• MDR Report Key: 4522835
• MDR Text Key: 18918524
• Report Number: 4522835
• Device Sequence Number: 1
• Product Code: NLN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: T12MH25L
• Device Lot Number: 0209038024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2015
• Patient Sequence Number: 1
• Patient Age: 48 YR