MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX LEGEND; MOTOR, DRILL, PNEUMATIC

Model Number T12MH25

Device Problem Break (1069)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

While the surgeon was using the medtronic burr handpiece, the tip broke off into the hand piece and in the patient.The patient was not harmed, all broken pieces were removed from the sterile field and a new burr tip was opened.

• Brand Name: MIDAS REX LEGEND
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 826 coal creek circle; ms ss-54; louisville CO 80027
• MDR Report Key: 16407899
• MDR Text Key: 309878620
• Report Number: 16407899
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2023

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: Health Professional
• Device Model Number: T12MH25
• Device Catalogue Number: T12MH25
• Device Lot Number: H5635404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Weight: 78 KG