MAUDE Adverse Event Report: BRIVANT LTD. T/A LAKE REGION MEDICAL VICTORY 18 (300CM, 30G)

Model Number 901023-32

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event Description

It was reported that: victory 18 300cm sheared end.

Event Description

It was reported that: victory 18 300cm sheared end.

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

• Brand Name: VICTORY 18 (300CM, 30G)
• Type of Device: VICTORY 18 (300CM, 30G)
• Manufacturer (Section D): BRIVANT LTD. T/A LAKE REGION MEDICAL; parkmore west business park; galway, ; EI
• MDR Report Key: 9339968
• MDR Text Key: 199099410
• Report Number: 3006010712-2018-00038
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K120137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901023-32
• Device Catalogue Number: H74939233300300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other