MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE KIT, NO NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Model Number 283913000

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, fluid was leaking from the pump.The physician used another one product the same type.Procedure was completed successfully with no delay.There were no consequences for the patient.This report is for a confidence kit, no needles.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.H3, h4, h6: the dhr of product code: 283913000.Lot : 298997.Was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 14.01.2021.Qty: (b)(4).Visual inspection: the confidence kit, no needles (p/n: 283913000, lot #: 298997) was returned and received at us customer quality (cq).Upon visual inspection, only confidence pump assembly, the cement reservoir was returned from the kit.The cement was hardened inside the cement reservoir and there was sterile water inside the pump.No other issues were identified with the returned device that could impact the device functionality.Functional test: a complete functional test could not be performed due to the solidified cement.However, when the handle was twisted to transfer the sterilized water through the connector, the connector component was functioning as intended.The sterilized water was leaking without entering into the cement reservoir, this could be due to the solidified cement in the cement reservoir.Can the complaint be replicated with the returned device? yes.Dimensional inspection: a dimensional inspection was not performed as the internal components of the pump and the connector were inaccessible without destruction of the device.Document/specification review: the current and manufactured revision of drawings were reviewed: confidence, final packaging assembly.Confidence pump assembly.Confidence pump body assembly.Confidence pump piston assembly.Complaint confirmed? yes.Investigation conclusion the complaint condition was not confirmed for the confidence kit, no needles (p/n: 283913000, lot #: 298997).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.The confidence spinal cement system kit¿s instructions for use states that the cement should be stored unopened in its original packaging, in a dry, clean place away from light, at a maximum temperature between 41° f (5° c) and 77° f (25° c).Working time at operating room and material temperature of 20 degrees celsius is 9 minutes.The handling characteristics and setting time can vary if the product has not been fully equilibrated at 68° f (20° c) before use.The unopened product should be stored at 68° f (20° c) for a minimum of 24 hours before use.No other potential defects were observed.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.

Event Description

This is report 1 of 2 for (b)(4).

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• 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: 12319666
• MDR Text Key: 266639457
• Report Number: 1526439-2021-01691
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 298997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 08/26/2021
• Supplement Dates FDA Received: 09/23/2021
• Patient Sequence Number: 1