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

Model Number	MR8-T12BA30D
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: mr8-at10, serial/lot #: (b)(6), udi#: (b)(4); product id: mr8-tt12amis, serial/lot #: (b)(6), udi#: (b)(4).H3: (pli 10 - mr8-t12ba30d) product analysis: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.H3: (pli 20 - mr8-at10) product analysis: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.H3: (pli 30 - mr8-tt12amis) product analysis: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that patient was diagnosed with a pituitary tumor and during the endoscopic transsphenoidal resection procedure, the micro burr head mr8-t12ba30d was fractured.When using this consumable the power system drill bit became stuck and could not operate causing the handpiece bearing to break and making it unusable.This affected the progress of the surgery, but the doctor promptly replaced the consumable and completed the procedure.At the time of the report, there was no known impact to a patient.It was also reported that there was no damaged piece remained in the patient's body, and there was five minutes delay in procedure.The procedure was completed with backup product(s).Additional information was received stating the that there was no patient or staff impact, eight minutes delay in procedure and no i ntervention performed.
Additional Manufacturer Narrative
H3: (pli 10 - mr8-t12ba30d) product analysis: analysis was not performed because the device was determined to be lost.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: mr8-at10, serial/lot #: (b)(6), (b)(4) ; product id: mr8-tt12amis, serial/lot #: (b)(6) , udi#: (b)(4) h3: (pli 10 - mr8-t12ba30d) product analysis: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.H3: (pli 20 - mr8-at10) product analysis: evaluation could not reproduce the reported malfunction of tool stuck.It was noted that the no failure found.H3: (pli 30 - mr8-tt12amis) product analysis: evaluation determined that the cutting tool could not be pulled out.The likely cause of failure could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that patient was diagnosed with a pituitary tumor and during the endoscopic transsphenoidal resection procedure, the micro burr head mr8-t12ba30d was fractured.When using this consumable the power system drill bit became stuck and could not operate causing the handpiece bearing to break and making it unusable.This affected the progress of the surgery, but the doctor promptly replaced the consumable and completed the procedure.At the time of the report, there was no known impact to a patient.It was alsoreported that there was no damaged piece remained in the patient's body, and there was five minutes delay in procedure.The procedure was completed with backup product(s).Additional information was received stating the that there was no patient or staff impact, eight minutes delay in procedure and no i ntervention performed.

• Brand Name: MIDAS REX MR8
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24198380
• Report Number: 1625507-2026-00028
• Device Sequence Number: 13170571
• Product Code: HBE
• UDI-Device Identifier: 00763000514051
• UDI-Public: (01)00763000514051(17)280530(10)0226149981(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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-T12BA30D
• Device Catalogue Number: MR8-T12BA30D
• Device Lot Number: 0226149981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/02/2026; 03/09/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown