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

Model Number	5584099
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having revision surgery for the the removal of the existing l5 tsrh rp screw due to l5/s adjacent intervertebral disorder, l3/s fixation was performed in connection with l3-5.Followed by the insertion of a new solera screw on l5/s transforaminal lumbar interbody fusion (tlif) was performed.It was reported that the procedure encountered challenges due to pedicle hardening, causing the tip of the driver to break during screw insertion.Replacement driver were used, but that replacement driver also broke during screw removal.The screw size was adjusted from 7.5mm to 6.5mm, and the screw was eventually extracted using a short rod and reverse rotation with a power grip.These issues caused a delay of less than 60 minutes in the overall procedure time.There was no patient symptom reported.There were no further complications reported regarding the event.The allegation on screw was the rod piece and the screw were stuck on the distal side of the product.The damaged screwdriver tip remains in the screw crown.Since it was not possible to remove or insert with a normal screwdriver, it was fastened once with a short rod and grasped the rod with a rod gripper and removed.There was no malfunction against tsrh rp1 (unknown tsrh rp).Due to adjacent intervertebral disorder, the nail was pulled out to extend the fixation.No patient symptoms.The product was discarded in the hospital.
Additional Manufacturer Narrative
E1: first name and last name of initial reporter is unknown.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.
Additional Manufacturer Narrative
H3: product analysis of product:(b)(4), lot:sw19h018 visual and optical examination identified that the 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: LONGITUDE II
• 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: 22629162
• Report Number: 1030489-2025-02514
• Device Sequence Number: 7994329
• Product Code: LXH
• UDI-Device Identifier: 00643169163065
• UDI-Public: (01)00643169163065(11)191022(10)SW19H018
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: 5584099
• Device Catalogue Number: 5584099
• Device Lot Number: SW19H018
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2019
• 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: Unknown