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

Catalog Number	TFT30101T
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was an interbody fusion (l5/s) for lumbar degenerative disease on (b)(6) 2025.In the surgery, due to the severe degeneration, it was confirmed that the angle formed by the craniocaudal endplates was misaligned with the angle at which the inserters in question could be inserted.The surgeon attempted to rotate the implant, but the misalignment made it difficult.The surgeon finally managed to rotate the implant by hammering it and placed in the proper position.When the inserter was removed from the implant, its tip was deformed.This was thought to be due to the tip deforming to accommodate the difference in angle.Because the tip of the inner shaft had become deformed, it could no longer be removed from the outer shaft.The operation was completed without any problems, as the implant did not become stuck or require replacement.The surgery was completed successfully within 30 minutes surgical delay.The outer shaft was not damaged.However, the inner shaft, which can normally be pulled apart, could no longer be removed.No further information is available.
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 medwatch, a follow-up medwatch will be filed as appropriate.Product complaint # (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.Recaptured codes on h6 (health effect - impact code).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h3, h4, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found normal were marks, consistent with this type if reusable devices.The mating device remains inside the implant inserter outer shaft.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional evaluation was performed several attempts of disassembly the mating device was made.It was not possible to succeed due to the bent condition of the mating device.Therefore, the complaint allegation can be confirmed.However, no defect or malfunction was observed on the implant inserter outer shaft.The overall complaint was confirmed as the observed condition of the implant inserter outer shaft would have contributed to the complained 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 depuy synthes 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).The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 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: 23571130
• Report Number: 1526439-2025-01507
• Device Sequence Number: 13320258
• Product Code: MAX
• UDI-Device Identifier: 10705034557489
• UDI-Public: (01)10705034557489(10)NN180321
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 12/22/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 11/21/2025; 12/26/2025
• 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