MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS UNKNOWN; ARTHROSCOPE - DRILLS, BURRS, TREPHINES, & ACCESSORIES

Model Number DMOO10FAA

Device Problem Failure to Auto Stop (2938)

Patient Problem Brain Injury (2219)

Event Date 11/22/2016

Event Type  malfunction  

Event Description

During drilling hole for vp shunt the end piece of perforator kept drilling.Typically it stops once it hits bone.This caused a tear in the dura.The rn nurse in room notified operating room director, charge nurse, risk management, and the vendor.They were told to remove the item and any of that same item from the shelf for evaluation.Vendor called back stating he would be in late november.

• Brand Name: UNKNOWN
• Type of Device: ARTHROSCOPE - DRILLS, BURRS, TREPHINES, & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 6233277
• MDR Text Key: 64179257
• Report Number: 6233277
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DMOO10FAA
• Device Lot Number: 215/16
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR