MAUDE Adverse Event Report: DEPUY CMW - 9610921 UNK CEMENT DELIVERY DEVICE

Catalog Number UNK CEMENT DELIVERY DEVICE

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The primary surgery was performed on (b)(6) 2020 via bha.During the surgery, when the surgeon set the hose to the syringe, the plastic part of connecting point broke.The surgery was completed with backup device within 30 minutes delay.No further information is available.

• Brand Name: UNK CEMENT DELIVERY DEVICE
• Type of Device: CEMENT DELIVERY DEVICE
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10749665
• MDR Text Key: 214806697
• Report Number: 1818910-2020-23470
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT DELIVERY DEVICE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VMP ENDURANCE 80G.