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

Model Number	AD03
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report inconclusive.The ad03 and em100-a has been returned and are 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.(b)(6) number: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a craniotomy procedure, a non-medtronic codman (integra) perforator was used with a medtronic em100-a and an ad03 and it was reported that it did not stop which caused meningeal bleeding.On follow-up, no further information can be provided regarding the event.
Additional Manufacturer Narrative
Report not confirmed for ad03 ((b)(6)) and em100-a ((b)(6)).Evaluation could not reproduce the reported malfunction of continues to run.It was also noted that no anomalies were found.For the ad03 ((b)(6)), evaluation could not reproduce the reported malfunction of continues to run.However, it was noted that there were worn/contaminated components including the bearings, retainer ring and needle bearing.This finding may have contributed to the user¿s experience.It was also noted that the device runs a little bit rough and the laser markings were faded.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: 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: 10434306
• Report Number: 1625507-2020-00132
• Device Sequence Number: 2828458
• Product Code: HBB
• UDI-Device Identifier: 00763000084707
• UDI-Public: 00763000084707
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: AD03
• Device Catalogue Number: AD03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/22/2020
• 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: AD03( S/N:(B)(4),EM100-A (S/N:(B)(6),CODMAN
• Outcome Attributed to Adverse Event: Other