MAUDE Adverse Event Report: VILEX, LLC REDEMPTION DUO HINDFOOT NAIL SYSTEM; REDEMPTION DUO DISTAL TARGETING FRAME

Model Number	RD-TARG-DT
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Material Separation (1562); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sales representative notified vilex on 10/14/2024 of instrumentation malfunctions that occurred during a lower extremity charcot revision procedure.The following information was further provided by the sales rep on 10/21/2024: the targeting guide extender locked into place and locking cams fell off while inserting the nail with the mallet; the insertion tool adhered to the bottom of the targeting guide; targeting guide heel cup detached from internal component as it was being attached to the guide assembly.Vilex was made aware on 10/24/2024 of additional emdrs submitted by the facility regarding the same event.Report no.(b)(4).

• Brand Name: REDEMPTION DUO HINDFOOT NAIL SYSTEM
• Common Device Name: REDEMPTION DUO DISTAL TARGETING FRAME
• Manufacturer (Section D): VILEX, LLC; 111 moffitt street; mcminnville TN 37110
• Manufacturer Contact: emily womack ; 111 moffitt street; mcminnville, TN 37110 ; 8005215002
• MDR Report Key: 20674340
• Report Number: 1051526-2024-00002
• Device Sequence Number: 8370654
• Product Code: HSB
• UDI-Device Identifier: 00841731135155
• UDI-Public: (01)00841731135155(10)O5029
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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 Model Number: RD-TARG-DT
• Device Catalogue Number: RD-TARG-DT
• Device Lot Number: O5029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown