MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS DEPTH STOP TOOL LEGEND; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number DS1TD24

Device Problems Unintended System Motion (1430); Scratched Material (3020)

Patient Problems Hemorrhage/Bleeding (1888); Spinal Cord Injury (2432)

Event Type  Injury  

Manufacturer Narrative

No conclusion can be drawn.No evaluation was performed, as the device was discarded by customer.The user manual contains the following warning ¿do not use excessive pressure, such as bending or prying, on attachments or dissecting tools.This may cause tool to bend or break and cause injury to patient, operator and/or operating room staff.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that drill itself is simply to high speed and has a side cutting which leads to hemorrhage.On follow up it was confirmed that the patient had dural tear and bleeding.It was also noted that there is procedure delay and the patient is recovering from brain damage post surgery.Date of event notification: 2022-mar-10.

Manufacturer Narrative

For unknown motor and attachment: no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.The device user manual warnings section includes instructions to check the device for damage before use.If damage is found, the device should not be used.Pss unknown attachment (serial number: unknown) pss unknown motor (serial number: unknown).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.

Event Description

On further follow up it was reported that surgeon stated that drill bit is too sharp and the drill is too powerful for use in cranial procedures.

• Brand Name: DEPTH STOP TOOL LEGEND
• 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 ; 7000 central avenue ne; ft. worth, TX 76137-3291 ; 6122713209
• MDR Report Key: 14054530
• MDR Text Key: 288890243
• Report Number: 1625507-2022-00060
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DS1TD24
• Device Catalogue Number: DS1TD24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10..
• Patient Outcome(s): Other