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

Model Number 283905000

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

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in canada as follows: it was reported on (b)(6) 2022, that the pumps limp (metal) was unable to properly clamp to the seringue cement cap end- this caused hydraulic pressure and the sterile water was leaking.They simply placed the entire kit aside and used another 5cc confidence cement.No major delays as procedure was successfully completed.The patient was not impacted by this.This report is for one (1) confidence half dose kit (5cc) this is report 1 of 1 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, the section/field of the form is left blank.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received 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.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: a manufacturing record evaluation was performed for the finished device, it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.Product code: 283905000.Lot number: 324172.The product was released on: 09.09.2021 qty:(b)(4).The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects on the surface of the confidence half dose kit (5cc), p/n: 283905000.A dimensional inspection was unable to be performed due to being irrelevant to the complaint condition.A functional test was performed to assess the water leaking condition.After turning the pump clockwise, water started leaking from the connection between the pump and cement reservoir.The complaint condition was replicated.No allegation involving cement transfer was made.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the confidence half dose kit (5cc), p/n: 283905000 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this 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 ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15234971
• MDR Text Key: 302873580
• Report Number: 1526439-2022-01405
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209555
• UDI-Public: (01)10705034209555
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283905000
• Device Catalogue Number: 283905000
• Device Lot Number: 324172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1