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

Model Number 283913000

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted.Visual inspection: upon visual inspection, it was observed that only the hydraulic pump was returned from the confidence kit and there was some moisture observed inside the pump.No other issues were identified with the returned device.Functional test: the functional test cannot be performed on the returned device as the hydraulic pump was returned by itself.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed yes, the device received was leaking.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the confidence kit, no needles (p/n: 283913000, lot #: 244229).There is 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 history record (dhr) review was conducted: the dhr of product code 283913000, lot 244229, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on june 11th, 2019.Qty.(b)(4).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 during an unknown procedure on (b)(6) 2019, there was a pump issue.Surgeon used another same type of product to complete the procedure successfully.There was no patient consequences reported.During manufacturer's investigation of the returned device it was observed that only the hydraulic pump was returned from the confidence kit and there was some moisture observed inside the pump.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): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9772178
• MDR Text Key: 203903391
• Report Number: 1526439-2020-00634
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)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: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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: 244229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1