MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SPECIALS-THORACOLUMBAR; SCREWDRIVER

Model Number	X5597185
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having derotation of the spine at t2-l1 for scoliosis.It was reported that while derotation of the spine the tip cracked off the driver.The other driver is worn, after 1000 of uses, and the driver no longer retains the set screw.The adapter, after 100s of final tightening set caps, no longer retains the set screw ring after final tightening and set screw ring falls off the driver.There was no delay in the overall procedure time, and no fragment of the implant or instrument remaining in the patient.There was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3:product analysis of product no:x5597185, lot no:kc25d002 visual and optical examination identified it appears that part of the tip of the instrument has been broken off.The metal deformation gives indication that the failure was the result of overload.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: SPECIALS-THORACOLUMBAR
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 22640373
• Report Number: 1030489-2025-02517
• Device Sequence Number: 21256566
• Product Code: HXX
• UDI-Device Identifier: 00763000988524
• UDI-Public: (01)00763000988524(11)250421(10)KC25D002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: X5597185
• Device Catalogue Number: X5597185
• Device Lot Number: KC25D002
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/11/2025
• Date Device Manufactured: 04/21/2025
• 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: Female