MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS LEGEND TELESCOPING TUBE T12 CURVED; MOTOR, DRILL, PNEUMATIC

Model Number	TT12C
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3:no evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.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.
Event or Problem Description
It was reported that a defect when inserting the drill when tested.The drill does not reach the end of the tube and when shaking the tube, a noise is heard of a loose part inside it.There was no patient involved with this event.
Additional Manufacturer Narrative
H3: evaluation of the device determined tool that was returned with the product 10ba20d is not intended to be used with the telescoping tube/attachment.However, using a different telescoping tool, it was confirmed that the tool could not be fully inserted into the tube.Using a borescope, it was discovered that the inner race of bearing 900-0 had separated from the outer race and was loose inside the tube.The bearing was second from the most distal in the assembly.The suspected cause of failure is the bearing separated from the outer race and was loose inside the tube.It was also noted that tt12c telescoping tube and packaging for 10ba20d were received (no tool).No identifying markings are visible on the tube.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 TELESCOPING TUBE T12 CURVED
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20531492
• Report Number: 1625507-2024-01013
• Device Sequence Number: 8219221
• Product Code: HBB
• UDI-Device Identifier: 00613994418739
• UDI-Public: 00613994418739
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: TT12C
• Device Catalogue Number: TT12C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown