MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS TOOL MR8 F2/7CM TAPER 2.3MM DIAMETER; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number MR8-F2/7TA23

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

It was reported that the attachment disintegrated and internals fell out.It was reported that there is no patient impact.It was reported that no additional surgery required and procedure was completed with backup product.

Manufacturer Narrative

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 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.If damage is found, the device should not be used.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

No conclusion can be drawn.Device was returned and the evaluation anticipated but not yet begun.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

It was also reported that tool is broken.

Manufacturer Narrative

Inspection findings for concomitant device, mr8 af02, serial #(b)(6): evaluation determined that attachments is disintegrated.The likely cause of failure could not be determined.It was also noted bearings were worn.G4: corrected pma/510k 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.

Manufacturer Narrative

H3: product analysis for tool mr8-f2/7ta23: evaluation determined that tool is fractured/ broken at tip end.The likely cause of failure could not be determined.It was also noted removal and insertion difficulty meaning that the likely cause was identified as material transfer from a detached bearing.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: TOOL MR8 F2/7CM TAPER 2.3MM DIAMETER
• 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: 14286962
• MDR Text Key: 290775325
• Report Number: 1625507-2022-00082
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183515
• 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,Followup,Followup
• Report Date: 01/31/2024

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: MR8-F2/7TA23
• Device Catalogue Number: MR8-F2/7TA23
• Device Lot Number: H5743439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 09/08/2022; 05/30/2023; 01/24/2024
• Supplement Dates FDA Received: 10/10/2022; 06/30/2023; 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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: MR8-AF02, SERIAL# (B)(6).