MAUDE Adverse Event Report: MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX MR8; DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)

Model Number	MR8-9MC30
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon needed to remove screws that patient previously had from when he was younger.While trying to remove screws a midas rex metal cutting burr sheared off while being used as well as a sleeve from synthes broken screw removal set.X-ray notified, broken pieces removed from field.X-rays taken - radiologist confirmed no unexpected findings.Surgeon evaluated and reviewed films as well.No harm to the patient.

• Brand Name: MIDAS REX MR8
• Common Device Name: DRILLS, BURRS, TREPHINES ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC POWERED SURGICAL SOLUTIONS; 826 coal creek circle; ms ss-54; louisville CO 80027
• MDR Report Key: 15995131
• Report Number: 15995131
• Device Sequence Number: 5950030
• Product Code: HBE
• UDI-Device Identifier: 00763000506742
• UDI-Public: (01)00763000506742
• 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): 12/01/2022
• Report Date (Section F): 12/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: MR8-9MC30
• Device Lot Number: 0224091425
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/01/2022