MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MEDTRONIC REX LEGEND DRILL BIT

Catalog Number F2-B1

Device Problems Device Emits Odor (1425); Mechanics Altered (2984)

Patient Problem No Information (3190)

Event Date 01/29/2016

Event Type  malfunction  

Event Description

During procedure, while surgeon using a drill on an implant to be used, the drill bit produced a smell and became misshapen.Drill bit was immediately removed from field and replaced with different device.See also report mw5060589.

• Brand Name: MEDTRONIC REX LEGEND DRILL BIT
• Type of Device: DRILL BIT
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach street
• MDR Report Key: 5466722
• MDR Text Key: 39431433
• Report Number: MW5060588
• Device Sequence Number: 1
• Product Code: HTW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: F2-B1
• Device Lot Number: D6348-05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR