MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 5.5MM CANNULATED TAP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734300

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978); Mechanical Jam (2983)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

Medtronic received information regarding a navigation system used intraoperatively in a sacroiliac and thoracolumbar procedure in which there was patient involvement.It was reported that there was a damaged instrument.While using an attachment during the case, the drill got hung up in the instrument.The representative (rep) suspected that the attachment was damaged before the surgical technician inserted it into the instrument as they were setting it up for the case.Early on in the case, the surgeon made a statement that the instruments "didn't feel right." a short while later, once the attachment was stuck on the instrument, the drill torqued the instrument and the surgeon's hand.The surgical technician struggled to remove the attachment from the instrument, so they began banging the instrument with pretty significant force using a metal mallet to get it off of the attachment.After the surgical tech was able to remove the instrument from the attachment, the rep verified that the instrument was working as expected with the navigation system.The rep found there to be a visible groove ring around the instrument where it would connect with the instrument.There was no impact to patient outcome and surgical delay was reported as about 2 minutes.Additional information was received.It was reported that the instrument with the issue was stuck in rotation instead of turning freely.The instrument turned as the surgeon was holding it and caught and torqued his hand.After switching the tap, all instruments and worked within normal limits.The surgeon needed no care in regard to the instrument torquing his hand.He held his hand as if in mild pain for a few seconds and then continued with the surgery without further issue.

Manufacturer Narrative

H3, h6: 9734300 was returned to the manufacturer for analysis.After functional testing and visual/physical examination, the reported complaint was confirmed.The returned tap had severe galling on the back end which caused fit issues with the mating tracker.Codes b01, c07, and d02 are applicable to this analysis.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: 5.5MM CANNULATED TAP
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17379312
• MDR Text Key: 320042984
• Report Number: 1723170-2023-01312
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9734300
• Device Catalogue Number: 9734300
• Device Lot Number: 190710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 78 KG