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

Model Number	14BA40
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
14ba40: no conclusion can be drawn for 14ba40 as device is returned and evaluation is anticipated but not begun yet.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.Pm100: no conclusion can be drawn for pm100 as device is returned and evaluation is anticipated but not begun yet.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.The preventive maintenance/service manual for the legend system specifies service intervals for devices based on the hospital usage level.The maximum specified service interval is 24 months.Device has been in use for approximately 147 months with no record of factory service during this period.We will continue to track and trend this complaint type.Other relevant device(s) are: product id: p m100, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while trying to put back the bur into the pneumatic stylus motor was not able to hold the bur, the end of the bur was broken.Surgeon did an intraoperative scan during the surgery, no broken metal found in patient.On further follow up ,it was reported that there was no patient or staff impact associated with the event and there was no delay in surgical procedure as a result of this event.
Additional Manufacturer Narrative
14ba40: report confirmed.Evaluation determined that 14ba40 tool was broken.The likely cause was identified as tool was allowed to contact softer metal while rotating at speed which caused enough stress.It was also noted that corrosion and discoloration.Pm100: 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.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.
Additional Manufacturer Narrative
H3: product id# pm100 serial number# (b)(6): no conclusion can be drawn.No evaluation was performed, as the device was still in use, since there is no allegation on this device.Product id# 14ba40 lot no# h5622224: evaluation determined that the 14ba40 tool was broken.The likely cause was identified as the tool was allowed to contact softer metal while rotating at speed, which caused enough stress.It was also noted that there was corrosion and discoloration, as well as adhesion of donor metal to the edges of the head and the stem of the tool and the deposit was not removed during decontamination, which means that the deposit is fused with the tool.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LEGEND BALL DISSECTING TOOL
• Common Device Name: 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: 14560716
• Report Number: 1625507-2022-00107
• Device Sequence Number: 6084764
• Product Code: HBE
• UDI-Device Identifier: 00643169758018
• UDI-Public: 00643169758018
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 05/21/2024

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 Expiration Date: 07/08/2025
• Device Model Number: 14BA40
• Device Catalogue Number: 14BA40
• Device Lot Number: H5622224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 09/08/2022; 04/24/2024
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 10/04/2022; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown