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

Model Number 1845020

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

Product analysis stated customers reason for return was confirmed, the indigo angled attachment run for 1 minute at 60k speed, the test has been stopped early to prevent further damage.After 1 minute the angled attachment temperature on the distal rised to 123f, the angle to 115f and the base to 109f.The distal bearings were detached and the bur used for testing wobbled a lot while running.Some laser markings were 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.

Event Description

It was reported that during procedure indigo attachement was noisy and overheating.It was further stated overheating was noticed in less than a minute.The device was run at 52k speed in drilling mode.Irrigation was used and the procedure was completed with another attachment.There was no patient impact.

• Brand Name: IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL
• Type of Device: 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: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 19170372
• MDR Text Key: 341640398
• Report Number: 1625507-2024-00133
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00763000172879
• UDI-Public: 00763000172879
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Model Number: 1845020
• Device Catalogue Number: 1845020
• Device Lot Number: 218169553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1