MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 283913000

Device Problems Migration or Expulsion of Device (1395); Device-Device Incompatibility (2919); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

Device report from synthes reports an event in taiwan as follows: it was reported that during surgery on an unknown date, the cement injector and the cement bottle cap could not be tightly connected, causing the liquid to leak out during pressurization.The cement could not be removed and could not be used.There was no patient consequence.This report involves one confidence spinal cement system confidence kit spinal cement system.This is report 1 of 1 for pc:(b)(4).

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.B3: only the event year is known.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.

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.H3, h6: the device has been 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.

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.A product investigation was conducted.Photo evidence and product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of photo evidence and returned sample found cement has slightly passed the stablished limit of the reservoir; it is possible this condition can contribute to correct cement transfer.Potential cause of this condition cannot be established with available information.Assembling of cement reservoir cap and hydraulic pump flexible tube was able to be performed correctly, the overall assembling of the device can be performed with no problem; it is not possible to confirm an assembling issue.Surgical technique of confidence spinal system was reviewed and the following relevant notes were found at page 19 and 20: the reservoir cap must be fully seated against the flange on the cement reservoir.Ensure the piston inside the cap is properly attached to the cap before threading onto the reservoir.If the quick connect will not attach to the reservoir cap, rotate the handle of the pump counter-clockwise to relieve some pressure.This will allow the connector to attach to the cap.Cement lot number 4195608 is identified to be used with the confidence kit: lot number 381197.Retain test was performed for the cement lot number: 4195608.Lot: 4195608 manufacturing date: 01 jun 23 expiry date: 30 nov 25 quantity: (b)(4).Product checked: retained samples required testing: tm-t150 cement setting time the samples returned were tested in a temperature and humidity-controlled laboratory.Lot: 4195608 dough time: 42s (90s) mix characteristics: stiff setting time: 14 min 27s (12 min 00s to 24 min 00s).The cement mixed and behaved as expected for the product type and met the appropriate control specification (ref ms-040 confidence spinal bone cement master specification).Setting time was tested using tm-t150 (comparative test for tmt077).The recorded setting met the control specification.A functional test cannot be fully performed without liquid and since cement has already hardened, but an attempt was performed; the small quantity of liquid found on tube moved very slowly but did not leak.A dimensional inspection was unable to be performed due to condition of the complaint.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, the potential 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.A manufacturing record evaluation was performed for the finished device product code : 283913000 lot number: 381197 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 14-sep-2023 manufacturing site: (b)(4).Expiry date:31-aug-2025 cement number: product code: 183901001/ batch number: 4195608 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.

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18544989
• MDR Text Key: 333541151
• Report Number: 1526439-2024-00660
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 283913000
• Device Lot Number: 381197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 01/19/2024; 02/13/2024; 04/02/2024
• Supplement Dates FDA Received: 01/19/2024; 02/27/2024; 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1