MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SEXTANT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8670020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: part# 8670020; lot# (b)(6) visual and optical examination identified it appears that part of the driver's tip has been sheared off and the rest of the tip is twisted.The metal deformation gives indication that the failure was the result of torsional overload.This regulatory report is being submitted due to retrospective review through capa 624392.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 olif l3-5 for d egenerative disc disease l3-5.It was reported that while the surgeon was removing previously placed hardware at l5, the screwdriver broke.A new driver was opened and the case carried on with no issue.There was no patient symptom reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that the device came in contact with the patient.

• Brand Name: SEXTANT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 21362324
• Report Number: 1030489-2025-00741
• Device Sequence Number: 8452503
• Product Code: LXH
• UDI-Device Identifier: 00721902279317
• UDI-Public: 00721902279317
• 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
• Report Date (Section B): 02/12/2025

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: 8670020
• Device Catalogue Number: 8670020
• Device Lot Number: SW18A082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2023
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2018
• 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: 50 YR
• Patient Sex: Unknown