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

Model Number	MR8-14MH30T
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was performing a 3 level posterior lumbar interbody fusion (plif) surgery, placing 8 screws.While placing the 5th screw they complained that the bit was dull and they wanted a new one.It was noticed there was a lot of smoke coming out of the incision site.When the drill was passed back, it was noticed the bit had turned black and blue and it had blue residue on it from burning a hole through the drapes.A wet raytec was put on it to cool it down and it started to steam and make popping noises.The bit was switched out for a new one to drill the remaining screws and the bit again turning blue and black and was dull.The mr8 drill motor was warm as well.No patient impact was reported.It was also noted that the procedure was completed with the reported product.On follow up, it was confirmed with the health care professional that there was no patient or staff impact.
Additional Manufacturer Narrative
H3: product analysis: evaluation determined that dull and burning bit.The likely cause was identified as the burr tips are both corroded on each tool and both have signs of damage from excessive heat and corrosion by the brown and blue discolorations , he tips of the tools returned both are results of damage from that of the tools coming into contact with foreign metal during its use.This regulatory report is being submitted due to a retrospective review through capa 624392.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.

• 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: 21864503
• Report Number: 1625507-2025-01471
• Device Sequence Number: 17314499
• Product Code: HBE
• UDI-Device Identifier: 00763000490768
• UDI-Public: 00763000490768
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2025

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: MR8-14MH30T
• Device Catalogue Number: MR8-14MH30T
• Device Lot Number: 0227011108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• Patient Sex: Unknown