MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY

Model Number 283910000

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/14/2022

Event Type  malfunction  

Manufacturer 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.

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a surgery on (b)(6) 2022, when rotating the handle, it was noted that there was a leakage, the water flew out.Device was changed to another one to continue with the procedure, but the same problem happened again.Another device of other manufacturers was used to complete the surgery.There was no surgical delay.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) confidence spinal cmt sys, 11c.This is report 2 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 synthese 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 manufacturing record evaluation was performed for the finished device.Product code: 283910000.Lot number: 302607.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: april 12, 2021.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the confidence spinal cmt sys, 11c had no visual damages or product defects.Only the hydraulic pump, the hose, the rectus connector and the lid of the cement reservoir were returned.It was observed that the hydraulic pump was used almost all the way and only a small amount of water remained in the pump.No other issues were identified.The dimensional inspection was not performed due to the design of the device.A complete functional test could not be performed as the cement reservoir and the mating devices were not returned for evaluation.A partial functional test was performed by rotating the hydraulic pump piston clockwise and the pressure was building as intended.The water was flowing through the hose with no issues noted and did not leak from the rectus connector either.The complaint condition could not be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint could not be confirmed for the confidence spinal cmt sys, 11c.A definitive root cause cannot be determined for the reported complaint condition from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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.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 CMT SYS, 11C
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13550120
• MDR Text Key: 286510938
• Report Number: 1526439-2022-00236
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: (01)10705034209623
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• 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: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Device Lot Number: 302607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1