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

Model Number 1845010

Device Problem Self-Activation or Keying (1557)

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

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

Analysis found that could not replicate the reported fault , no fault was found.Cleaned and sanitized the unit.Conducted preventative checks including functional tests and heat test as per manufacturer's specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) reported that the bur was spinning out of control in the attachment.There was no delay in the surgical procedure.There was no patient or staff impact.

Event Description

On follow-up, it was reported that the straight attachment was not gripping the bur properly, the bur was loose in the attachment.For troubleshooting, they swapped out the attachment.It was noted that the straight attachment didn't immediately start to run when plugged into the power supply (console) and footswitch.The straight attachment didn't continue to run when no longer activated.

Manufacturer Narrative

Correction: aware date on initial regulatory report should be 2021-04-30 not 2021-02-09.This was based on follow-up information received.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 11945662
• MDR Text Key: 254487750
• Report Number: 1625507-2021-00131
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00613994933706
• UDI-Public: 00613994933706
• Combination Product (y/n): N
• PMA/PMN Number: K081475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1845010
• Device Catalogue Number: 1845010
• Device Lot Number: 211548334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2021
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1