MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ATLANTIS TRANSLATIONAL SCREWS AND INSTR; SCREWDRIVER

Model Number	7080907
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis part# 7080907; lot# kh16a148- visual and optical analysis revealed the hex edges of the driver are rolled over/stripped.This type of damage is consistent with torsional overload and repeated use overtime.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 a healthcare provider (hcp) via a medtronic representative regarding a patient implanted with a spinal product using drivers in an acdf at c4-7 for neck pain and radiculopathy.It was reported that the surgeon indicated during procedure that all the drivers in universal cervical tray are stripped and need to be replaced.There were no patient symptoms or complications as a result of this event.The reported products were already used multiple times previously.No further complications were reported/ anticipated.

• Brand Name: ATLANTIS TRANSLATIONAL SCREWS AND INSTR
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19534887
• Report Number: 1030489-2024-00671
• Device Sequence Number: 12896761
• Product Code: HXX
• UDI-Device Identifier: 00613994234087
• UDI-Public: 00613994234087
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

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: 7080907
• Device Catalogue Number: 7080907
• Device Lot Number: KH16A148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2016
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 113 KG