MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE HALF DOSE KIT (5CC); CEMENT, BONE, VERTEBROPLASTY

Model Number 283905000

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that on february 28, 2023, upon opening a large confidence cement kit and following the precise mixing instructions, the cement seemed to harden and when attaching the vial that is supposed to fill with cement, the vial did not fill and the cement appeared still grainy instead of smooth.A second large confident from the same lot.Again, the same issue occurred where the vial did not fill and the cement looked incorrect.All ingredients were mixed as measured and timed when mixing.Lastly, we opened a half dose 5cc confidence kit, and the goal of liquid was broken and unusable.No contact was made with patient.The surgery was surgery was successfully completed with surgical delay of 20 minutes.This complain involves three (3) devices.This report is for one (1) confidence half dose kit (5cc) this is report 2 of 3 for complaint (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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.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.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.H10 additional narrative: h4: part # 283905000 lot # 326233 supplier: affiliate selzach - batch1: lot qty of 02 units were released on (b)(6) 2022 with no discrepancies.- batch2: lot qty of 03 units were released on (b)(6) 2022 with no discrepancies.- batch3: lot qty of 05 units were released on (b)(6) 2022 with no discrepancies.- batch4: lot qty of 08 units were released on (b)(6) 2022 with no discrepancies.- batch5: lot qty of 01 units were released on (b)(6) 2022 with no discrepancies.- batch6: lot qty of 19 units were released on (b)(6) 2022 with no discrepancies.- batch7: lot qty of 07 units were released on (b)(6) 2022 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 HALF DOSE KIT (5CC)
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16592977
• MDR Text Key: 312224857
• Report Number: 1526439-2023-00564
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209555
• UDI-Public: (01)10705034209555
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 283905000
• Device Catalogue Number: 283905000
• Device Lot Number: 326233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONFIDENCE KIT, NO NEEDLES; CONFIDENCE KIT, NO NEEDLES