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

Catalog Number	283913000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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.Additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that there was a leak in the lower column.There was no patient consequence.
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: d1, d4 (catalog, primary udi number).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: added: d9.H3, h4, h6: the product was not returned to medtech orthopaedics, however video were provided for review.The video investigation of "283913000, confidence kit, no needles" revealed that the device is leaking.But based on the available evidence, a definitive root cause could not be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the confidence kit, no needles would contribute 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 complaint condition.As part of 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: a dhr evaluation was performed for the finished device, product code: 283913000, lot number: 418913, it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 13 dec 2024, manufacturing site: jabil le locle.If information is obtained that was not available for the initial report, a follow-up report 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, h6 video investigation: the product was not returned to medtech orthopaedics, however video were provided for review.The video investigation of "283913000, confidence kit, no needles" revealed that the device is leaking.But based on the available evidence, a definitive root cause could not be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the confidence kit, no needles would contribute 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 complaint condition.As part of 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.Physical product investigation: the product was returned to j&j medtech orthopaedics for evaluation and it was send to the manufacturing site for further analysis.Note: the complaint device was evaluated and investigated by the manufacturing site.Please refer to the attachment: 28_mfg_investigation_form_(b)(4).Investigation results.Upon receipt of the returned device by jabil le locle, a pressure test was performed to investigate the customer-reported leak condition.This re-test confirmed the presence of a water leak at the pump connector, as evidenced in the attached photograph.To ensure a rigorous and comparable assessment, the device was re-tested under the same controlled manufacturing conditions as the original 100% in-process test.To ensure a rigorous and comparable assessment, the device was re-tested under the same controlled manufacturing conditions as the original 100% in-process test.The confidence hydraulic pump manufacturing process was completed without any deviations or non-conformities.All units passed in-process pressure testing, and no water leakage was observed at any stage of production.The pump connector where there is the leakage was disassembled and show that the o-ring is present and not damaged.The complaint alleges a water leak at the pump connector.While the customer has confirmed the presence of a leak upon receipt, investigation into jabil le locle's manufacturing processes reveals no evidence of manufacturing defect or deviation.Therefore, the pressure integrity loss cannot be attributed to manufacturing failures at jabil le locle and does not constitute a product liability claim against the manufacture 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, the potential cause cannot be established, and 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 lot a dhr evaluation was performed for the finished device product code: 283913000 lot number: 418913 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 13-dec-2024 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 Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22742526
• Report Number: 1526439-2025-00955
• Device Sequence Number: 8506986
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630(10)418913
• 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: Physician
• 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: 418913
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 08/29/2025; 12/15/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/15/2025; 08/29/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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