MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. TL REVISION INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8361025
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l4/5 plf.Preoperative diagnosis of this surgery was adjacent intervertebral disorder.It was reported that the screw became stripped and could not be removed; were able to remove three of the screws with a remover screwdriver, but one remained in place.The 8110530 x10 remover screwdriver lock 3.0mm was mistakenly used.There were no patient symptoms reported.There were no further complications reported regarding the event.Additional information was received from the manufacturer representative that the 3.2mm driver was not used and it had no problems.The screw removal drivers grip became loose and it couldn't be pulled out all four screws that were originally in it.This surgery is to replace it with an implant made by another company.It is not a defect of the screw.After obtaining bone fusion after l4/5plf, adjacent intervertebral disorders occurred and reoperation was required.The surgeon doctor is currently using another company's product, and instead of using a revision that is an extension of 3dx, he planned to remove all 3dx once (l4/5) and perform a revision operation (l2/3/4/5) with another company's product.Bone fusion of l4/l5 at the initial fixation site was completed.For safety, a fixation up to l5 was planned, but the screw could not be removed, so a new implant could not be placed in l5.However, the physician in charge has determined that there will be no problems without fixation because the bone fusion of l4/l5 has been completed.
Additional Manufacturer Narrative
G2: country of origin is japan.H3: product analysis: product # 8361025 lot# jm0027 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: TL REVISION INSTRUMENTS
• 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: 23614812
• Report Number: 3003120897-2025-00605
• Device Sequence Number: 10090771
• Product Code: LXH
• UDI-Device Identifier: 00721902468810
• UDI-Public: (01)00721902468810(11)060502(10)JM0027
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: 8361025
• Device Catalogue Number: 8361025
• Device Lot Number: JM0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2006
• 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