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

Model Number 8TA11

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/12/2022

Event Type  Injury  

Event Description

The 2 mm tip of medtronic midas rex drill burr broke off inside surgical wound.Surgeon noted artifact on post op mri and ordered a ct for clarification.Patient to operating room on (b)(6) 2022 for a craniotomy for tumor.Following day when surgeon reviewed post op mri, he noted artifact on the scan and order ct.He confirmed that there as an approximately 2 mm piece of metal left in the surgical wound.Surgeon suspected it was tip of metal burr.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC MIDAS REX
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS
• MDR Report Key: 15673575
• MDR Text Key: 302489061
• Report Number: MW5112845
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8TA11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White