MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS PSS UNKNOWN TOOL; MOTOR, DRILL, PNEUMATIC

Model Number	MR8-15BA60D
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3:pss unknown tool# no conclusion can be drawn.Device returned.Evaluation anticipated but not yet begun.Mr8-ava15: evaluation could not reproduce the reported malfunction of detachment of component.It was also noted that tube is worn.The input and output shaft is worn and laser markings are fading.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m r8-ava15, serial/lot #: (b)(6), ubd: , udi#: (b)(4).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
Repair request initiated for device with the report of detachment of component.It was reported there was no patient involvement.Repair is being escalated to product event due to reason for the return and on evaluation due to tool is broken.
Additional Manufacturer Narrative
H3:product analysis for mr8-15ba60d with lot#0229351896:evaluation of the device determined tool received used with head detached and missing.Significant charring at distal end of stem, and marring at location of distal bearing.The likely cause of failure that the tool was used in an attachment with a failed bearing.Instability during cutting led to fracture.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: PSS UNKNOWN TOOL
• 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: 21147194
• Report Number: 1625507-2025-00044
• Device Sequence Number: 9117861
• Product Code: HBB
• UDI-Device Identifier: 00763000491048
• UDI-Public: 00763000491048
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/24/2025

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: MR8-15BA60D
• Device Catalogue Number: MR8-15BA60D
• Device Lot Number: 0229351896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• Patient Sex: Unknown