MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX BALL DIAMOND 5MM; MOTOR, DRILL, PNEUMATIC

Model Number 10BA50DX

Device Problem Break (1069)

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

Event Date 01/22/2021

Event Type  Injury  

Event Description

Midas rex burr broke while in use; ball shaped end piece snapped off of the shaft.Was immediately observed by surgeon and staff and all parts were removed from surgical field, replaced with new tool, surgery continued as planned.Fda safety report id # (b)(4).

• Brand Name: MIDAS REX BALL DIAMOND 5MM
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS ; fort worth TX 76137
• MDR Report Key: 11377917
• MDR Text Key: 233782188
• Report Number: MW5099615
• Device Sequence Number: 1
• Product Code: HBB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/22/2021

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: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 10BA50DX
• Device Catalogue Number: 10BA50DX
• Device Lot Number: H5620679
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 96