MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND PERFORATOR ATTACHMENT; MOTOR, DRILL, PNEUMATIC

Model Number	AD01
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Injury (2348); Unspecified Tissue Injury (4559)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.The device has been returned and is still pending their evaluation results.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.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a case, the attachment and motor seized.The motor was replaced, however it was found out that the attachment has the problem.It was reported that the delay in the procedure may have caused impact to the patient that was brought to the icu.Additional information about the event is being followed up from the facility contact person.
Additional Manufacturer Narrative
Report confirmed.Evaluation determined that the attachment seized.The likely cause was identified as corroded shaft and bearings.It was also noted that the laser markings were corroded.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 or Problem Description
On follow-up, no further information can be provided regarding the status of the patient post-surgery.
Event or Problem Description
On follow-up, it was reported that the event happened during evacuation of subdural hematoma.Initially, two pneumatic motors were used with the ad01, but it was not working.Then, it was replaced by an em200 and was used to create a burr hole, turn a flap, and gain access to the subdural hematoma.It was also reported that there was a 15-20 minute procedure delay to change the device and identify the root cause of the failure.There was no further information regarding the serial numbers of the reported pneumatic motors.
Additional Manufacturer Narrative
No conclusion can be drawn for the two pm700.No evaluation was performed, as these devices were not returned.If these devices were returned in the future, product analysis may be performed.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.

• Brand Name: LEGEND PERFORATOR ATTACHMENT
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• MDR Report Key: 10708413
• Report Number: 1625507-2020-00193
• Device Sequence Number: 11544558
• Product Code: HBB
• UDI-Device Identifier: 00721902481925
• UDI-Public: 00721902481925
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AD01
• Device Catalogue Number: AD01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 01/08/2021
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 11/17/2020; 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PM700 (UNKNOWN SERIAL NUMBERS).; UNKNOWN MOTOR.
• Outcome Attributed to Adverse Event: Other