MAUDE Adverse Event Report: MDT Powered Surgical Solutions MIDS REX MR8; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-10BA50DX
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Dural Tear (1417); Cerebrospinal Fluid Leakage (1772); Hypovolemia (2243); Hydrocephalus (3272)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a surgical procedure, decompression was performed under general anesthesia at l2/3 on the right, with c ontralateral over-the-top decompression on the left, as well as left-sided decompression at l4/5.During the l2/3 decompression, the drill unexpectedly became blocked and subsequently malfunctioned.At the same time, the patient made a sudden and forceful movement of the lower limb despite general anesthesia.Microscopic inspection revealed a focal dural opening adjacent to the right l3 nerve root with low-volume csf leakage.An intraoperative nerve root injury was suspected.The decompression was carefully continued, andthe right l3 nerve root and contralateral spinal canal were adequately decompressed.The dural opening was treated locally with tachosil.Hemostasis was achieved, and a valsalva maneuver at the end of the repair showed no persistent csf leakage.Additional information was received from the surgeon clarified that the instrument remained securely held, but the burr attachment suddenly thrust forward while operating at full speed.The event occurred within milliseconds without warning, and the exact mechanism could not beconfirmed retrospectively.The incident occurred at the beginning of the procedure while the ligamentum flavum and part of the bone were still protecting the dura and neurological structures.At that moment, the patient made a sudden and forceful movement of the lower limb.Based on the sequence of events, the surgeon considered the sudden forward movement of the rotating burr attachment to be the most likely explanation for the subsequent injuries.Immediately afterward, the motor stopped functioning and could not be restarted, and no error code was displayed.The surgeon noted that the remaining ligamentum flavum and bone provided some protection to the neurological structures.
Additional Manufacturer Narrative
H3: product analysis: no conclusion can be drawn.No evaluation was performed, as the device was device discarded by customer.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: MIDS 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 ; +1(763)526-5677
• MDR Report Key: 50916753
• Report Number: 1625507-2026-08252
• Device Sequence Number: 5370284
• Product Code: HBE
• UDI-Device Identifier: 00763000487317
• UDI-Public: (01)00763000487317(17)310616(10)0233792679(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• 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
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MR8-10BA50DX
• Device Catalogue Number: MR8-10BA50DX
• Device Lot Number: 0233792679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown