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

Model Number	MR8-23TD3030
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During case, a sterile, single use 23 cm 3.0 medtronic twist drill was opened.Or team immediately noted that drill bit was discolored and appeared to be contaminated.Item was immediately given to or case manager and company vendor notified.No harm to patient.Drill bit never reached the patient or the sterile field.Drill bit ref #mr8-23td3030, lot #0223111521.Device available in case manager's office.Company vendor will report to medtronic case manager.

• Brand Name: MIDAS REX
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 4620 north beach st; fort worth TX 76137
• MDR Report Key: 19689083
• Report Number: 19689083
• Device Sequence Number: 20621952
• Product Code: OLO
• UDI-Device Identifier: 00763000335793
• UDI-Public: (01)00763000335793
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2024
• Report Date (Section F): 03/15/2024

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 Model Number: MR8-23TD3030
• Device Lot Number: 0223111521
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 22 DA
• Patient Sex: Male
• Date Report Sent to FDA: 03/15/2024