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

Model Number 283913000

Device Problem Chemical Problem (2893)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

The dhr of product code: 283913000.Lot : 294149.Was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: 30.11.2020.Qty: (b)(4).Visual inspection: the confidence kit, no needles (p/n: 283913000, lot #: 294149) was returned and received at us customer quality (cq).Upon inspection of the returned device, it was observed that only the mixer handle and the mixer bowl were returned and the entire kit was not returned.The components of the mixer handle fell apart and the residue of cement was observed to be hardened on the mixer handle and the mixer bowl.No other issues were identified with the returned device.Device failure/defect identified? yes.Functional test: an overall functional test could not be performed due to the solidified cement.However the components that fell apart could have caused the complaint condition.Can the complaint be replicated with the returned devices? yes.Document/specification review, confidence cement reservoir & mixer kit, confidence assembly, mixer handle, confidence, mixing well.Dimensional inspection: complaint relevant dimensional inspection could not be performed due to the solidified cement and the device geometry.Complaint confirmed? yes.Investigation conclusion the complaint condition could be confirmed for the returned device as the returned device was observed to have fell apart.There was no indication that a design or manufacturing issue has caused the issue 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.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 an unknown date that the mixer stopped working and fell into pieces.There were no consequences for the patient reported.The procedure was completed using another one.This report is for one (1) confidence kit, no needles.This is report 1 of 1 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
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12537253
• MDR Text Key: 273576350
• Report Number: 1526439-2021-02081
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: 10705034209630
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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: 294149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1