MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS STEALTH MIDAS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number EM200N

Device Problems Blocked Connection (2888); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

Surgery neuro coordinator notified central sterile processing manager that the medtronic stealth midas rex line-powered surgical power tool system motor that came back from repair the previous day was still not working.The burr would still not attach which was noticed while setting up for the case.There was no delay in the original intended procedure.

• Brand Name: STEALTH MIDAS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st.; fort worth TX 76137
• MDR Report Key: 11900701
• MDR Text Key: 253151416
• Report Number: 11900701
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EM200N
• Device Catalogue Number: EM200N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Date Report to Manufacturer: 05/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA