MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	1845020
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tightening the parts by hand on handpiece was extremely difficult and the devices overheats.There was no patient impact.Post event handpiece was retested by customer and there was no fault found.
Additional Manufacturer Narrative
H3: analysis mentioned customer's reason for return has been confirmed.The bearings are corroded.The laser markings are faded.H6: imdrf annex codes b01, c1101, c0601, d02 are applicable for this product continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 1845010, serial/lot #: (b)(6), udi#: (b)(4) ; h3:analysis mentioned the customer complaint couldn't be confirmed.Pre-repair temperature check performed at 60k after 5 minutes the front temperature was 85f and the back temperature was 85f and are within limits.The ambient temperature was 76f.The laser markings are faded.The bearings are slightly corroded.H6: imdrf annex codes b01, c0601, d14, d02 are applicable for this product continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 1845000, serial/lot #: (b)(6), udi#: (b)(4).H6: imdrf annex codes b17, c20, d14 are applicable for this product 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
H3: analysis mentioned customer's reason for return has been confirmed.Pre-repair temperature test results for 1 min were at angle 92, base 90, distal bearing 89 within limits, but overheating noticed after 3 min usage.The bearings are corroded.The laser markings are faded.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: 1845010, serial/lot #: (b)(6), udi#: (b)(4); h6: imdrf annex codes d20 are applicable for this product continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 1845000, serial/lot #: (b)(6), udi#: (b)(4).H6: imdrf annex codes d20 are applicable for this product.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: IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL
• 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 ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 24386761
• Report Number: 1625507-2026-00069
• Device Sequence Number: 10518709
• Product Code: HBE
• UDI-Device Identifier: 00763000172879
• UDI-Public: (01)00763000172879(11)181203
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 1845020
• Device Catalogue Number: 1845020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 02/18/2026; 03/09/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown