MAUDE Adverse Event Report: DEPUY SPINE INC CONDUIT CURVED TLIF TRANSFORAMINAL LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	TFT30101T
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: h3, h6 investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the distal tip was stripped and visually deformed due to repetitive usage.The observed condition was identified as an end-of-life indicator, damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A functional test was performed with returned with the mating knob (tft20102t), and resistance due to damaged threads of the mating component was noted.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the implant inserter outer shaft would have contributed to the device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): a review of the receiving inspection (ri) for implant inserter outer shaft, was conducted identifying that lot number nn180321 released in one batch.Batch1: lot qty of (b)(4) units were released on aug 12, 2022 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.
Event or Problem Description
It was reported that the implant outer shaft and the knob inverter when twisted/ assembled got stuck, and during the process of disassembly it released filings/ metal parts.Some are stuck on the knob inserter.The surgery was not delayed, and there was no patient consequence.Upon return to the manufacturer, it was noted that the implant inserter outer shaft was stripped.

• Brand Name: CONDUIT CURVED TLIF TRANSFORAMINAL LUMBAR INTERBODY IMPLANT INSERTER OUTER SHAFT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22439010
• Report Number: 1526439-2025-00854
• Device Sequence Number: 4631808
• Product Code: MAX
• UDI-Device Identifier: 10705034557489
• UDI-Public: (01)10705034557489(10)NN180321
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K210728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: TFT30101T
• Device Lot Number: NN180321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown