MAUDE Adverse Event Report: MEDICREA INTERNATIONAL SA MEDICREA LEGACY TL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	A24000000
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Device evaluation summary: product analysis # (b)(4): part # a24000000 lot # 21j0466.A visual inspection revealed that the handle was twisted on the shaft.Functional testing determined that the handle is loose.This report is being submitted as part of remediation activities associated with capa pr 722573.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
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l3-s2 spinal fusion procedure with interbodies at l3-s1.It was reported that the inserter could not handle the required torque and broke.Pliers were used on the tightening mechanism to complete the implant rotation without the handle loosening.No patient complications have been reported as a result of this event.

• Brand Name: MEDICREA LEGACY TL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer (Section G): MEDICREA INTERNATIONAL SA; 5389 rte de strasbourg; rillieux la pape,fr 69140 ; FR 69140
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23629417
• Report Number: 1000432246-2025-00030
• Device Sequence Number: 9536878
• Product Code: LXH
• UDI-Device Identifier: 03613720286677
• UDI-Public: (01)03613720286677(11)241127(10)21J0466
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K241164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: A24000000
• Device Catalogue Number: A24000000
• Device Lot Number: 21J0466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1000432246-11/10/2025-00
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Male