MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY

Model Number 283910000

Device Problems Chemical Problem (2893); Failure to Eject (4010)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2020

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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that in the surgery room at 16 °c, the cement at 2 minutes and 10 seconds, when finished mixing the powder plus the liquid and going to the cement reservoir, it already had a hard consistency.Also, the hose anchor (female coupling of the manually operated pump) does not connect to the cap of the cement reservoir.This prevented using the kit.The cement forged in a very short time and the manual removal pump did not connect to the reservoir, the pressure caused the water contained in it to flow back through the proximal end of it and not even 1ml entered the vertebral body and the cement had already set.There was a surgical delay of ten (10) minutes.This report is for one (1) confidence spinal cement system confidence plus kit spinal cement system 11cc.This is report 1 of 1 for (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.H11 corrected data.H4.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: h3, h6: the device history record (dhr) of product code 283910000, lot 267164, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on (b)(6) 2020.The coupling rectus connector's sleeve component was found to be in its appropriate resting position.No additional functional assessment could be made.No damage or defect was noted to any component of the device.The device was not returned.Images were reviewed during investigation.One image depicted a flexible tube connector and cement reservoir cap were not connected.Another image depicted the device's label.No functional connection issue was observed during review of the image; no damage was noted to any component and the coupling rectus connector's sleeve appeared to be in the appropriate resting position.No malfunction, issue, defect, or damage was noted in the images.Additionally, there was no evidence of an abnormal cement setting time issue.A dimensional inspection, document/specification were not completed as the device was not returned.Conclusion the complaint conditions were not confirmed during investigation.No manufacturing or design issues were identified during investigation.It is possible the the pump and tubing were pressurized, which could contribute to the reported complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: h3, h6: a product investigation was completed: upon visual inspection it can be seen that the cement was hardened inside the injector body.Some portion of the hardened cement was found inside the transfer adapter.No other issues were identified with the returned device.The functional test could not be performed on the returned device as the cement was solidified.Based on the review of the relevant drawings, no design issues contributing to relevant complaint condition were identified.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.There is a possibility the cement may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement¿s setting time.No other potential defects were observed.No new malfunctions were observed during this investigation that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: h3, h6: the device was 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.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10393117
• MDR Text Key: 203131284
• Report Number: 1526439-2020-01461
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: 10705034209623
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/20/2020

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 Model Number: 283910000
• Device Catalogue Number: 283910000
• Device Lot Number: 267164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 08/18/2020; 11/19/2020; 11/20/2020
• Supplement Dates FDA Received: 08/14/2020; 09/15/2020; 11/19/2020; 12/10/2020
• Patient Sequence Number: 1