MAUDE Adverse Event Report: LAKE REGION MEDICAL VICTORY 18 (300 CM, 30G)

Model Number	901023-32
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
During the placement of a victory wire into a.018 navicross, the distal end of the victory wire got stuck in the navicross and broke off.They entire navicross and victory wire was removed from the patient.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: a new navicross and victory wire was used what is the next course of action?: no further action required patient present at time of event?: yes patient complications: no patient complications device acquired from a distributor?: no.
Event or Problem Description
During the placement of a victory wire into a.018 navicross, the distal end of the victory wire got stuck in the navicross and broke off.They entire navicross and victory wire was removed from the patient.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: a new navicross and victory wire was used what is the next course of action?: no further action required patient present at time of event?: yes patient complications: no patient complications device acquired from a distributor?: no.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem Description
During the placement of a victory wire into a.018 navicross, the distal end of the victory wire got stuck in the navicross and broke off.They entire navicross and victory wire was removed from the patient.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: a new navicross and victory wire was used what is the next course of action?: no further action required patient present at time of event?: yes patient complications: no patient complications device acquired from a distributor?: no.

• Brand Name: VICTORY 18 (300 CM, 30G)
• Common Device Name: VICTORY 18 (300 CM, 30G)
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 16495813
• Report Number: 3006010712-2023-00006
• Device Sequence Number: 17737815
• Product Code: DQX
• UDI-Device Identifier: 08714729826736
• UDI-Public: 08714729826736
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 901023-32
• Device Catalogue Number: H74939233300300
• Device Lot Number: 7456911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 02/23/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/13/2023; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown