MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	283913000
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The thruster joint is leaking, and the pressure is not high enough to push the cement.There was no patient consequence.
Additional Manufacturer Narrative
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
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: corrected: g1.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the cement reservoir had hardened cement inside, a small leakage was observed on the top.Hydraulic pump was received empty therefore leakage could not be confirm for this device.An interaction between the reservoir and the hydraulic pump was made and found no issues to connect and disconnect.The confidence spinal cement system¿ surgical technique 501032036 rev.A states the following: instructions: push and screw the cement reservoir adapter onto the mixing bowl with a clockwise rotation until firmly seated in the bottom of the bowl.This process will force the cement into the cement reservoir.Once the cement is visible at the distal tip of the cement reservoir, unscrew the cement reservoir from the cement reservoir adapter with a counterclockwise rotation.A small amount of cement may flow from the reservoir tip and should be removed before assembly to the needle.Cement delivery connect the hydraulic pump flexible tube to the cement reservoir cap by pushing and snapping the quick connect assembly onto the cement reservoir cap.If the quick connect will not attach to the reservoir cap, rotate the handle of the hydraulic pump counterclockwise to relieve some pressure.This will allow the connector to attach to the reservoir cap.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, duration of the mixing and transfer process.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors a dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to performed due to condition of the received device.The complaint condition was not able to be replicated.The overall complaint was confirmed as the observed condition of the confidence kit, no needles 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: a dhr evaluation was performed for the finished device.Product code: 283913000.Lot number: 427489.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 11.03.2025 manufacturing site: jabil le locle.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.H11 additional narrative: added: d9.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: h6.Component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H6: the product was not returned to depuy synthes, however photos were provided for review.Photos were provided for review, however the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided contained insufficient evidence of the reported event.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 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 lot: a dhr evaluation was performed for the finished device.Product code: 283913000, lot number: 427489.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 11.03.2025, manufacturing site: jabil le locle.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24057166
• Report Number: 1526439-2026-00034
• Device Sequence Number: 13135258
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K060300
• 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,Followup,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: 283913000
• Device Lot Number: 427489
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 02/17/2026; 02/23/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/14/2026; 02/23/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown