MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH FEN OPEN CANNULA STRL; DISPENSER, CEMENT

Model Number 279726500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint : (b)(4).Maude report (mw5085969).(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A maude report from fda was sent (mw5085969).While cement was being inserted into the screw, the tip of the insertion device broke off.

Manufacturer Narrative

(b)(4).

• Brand Name: FEN OPEN CANNULA STRL
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8624742
• MDR Text Key: 145534761
• Report Number: 1526439-2019-51662
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10705034199528
• UDI-Public: (01)10705034199528
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 279726500
• Device Catalogue Number: 279726500
• Device Lot Number: LC31508
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1