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

Model Number 283913000

Device Problem Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted: investigation flow: device interaction/functional.Visual inspection: the entire system was returned (pump assembly, mixer handle assembly, injector body and transfer adapter sub-assembly).In the pump assembly there is a small volume of the cement mix in the pump of the cement system and would not disperse.The cement mix appears to be a liquid.In the mixer handle assembly, there is some cement inside that has hardened.In the injector body there is cement inside that has hardened.No other issues were noted.Function test: a functional test was performed as all the parts mentioned above were reassembled per the technique guide and the complaint condition was confirmed as the pump assembly would not disperse into the injector needle because of the hardening of the cement prematurely to use.Dimensional inspection: a dimensional analysis was not performed as relevant to the complaint condition of will not transfer.Document/specification review: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.A potential root cause may be environment factors related to the storage of the cement.The confidence spinal cement system kit¿s instructions for use (ifu-0902-90-055 rev.8) 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.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed 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.A device history record (dhr) review was conducted: the dhr of product code 283913000, lot 244652, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on june 12, 2019.Qty.48.The dhr was electronically reviewed,the dhr of product code 283913000, lot 244652, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on june 12, 2019.Qty.48.The dhr was electronically reviewed.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the hydraulic pump of confidence vba system- cannot push the cement out of the pump.The surgery was completed with 60 minutes delay.There was no fragment generated.There were no patient consequences.This complaint involves one (1) device.This report is for (1) confidence kit, no needles.This is report 1 of 1 for (b)(4).

• Brand Name: CONFIDENCE KIT, NO NEEDLES
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10426547
• MDR Text Key: 205553764
• Report Number: 1526439-2020-01491
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: 10705034209630
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 244652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1