MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; LAPIDUS CORRECTION JIG, RIGHT

Catalog Number	3400-06-000
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument breakage - 30 minute delay in surgery.
Additional Manufacturer Narrative
Confirmed the correction knob separated from the jig.The compression screw is jammed, and the distraction knob/screw gets stuck/jammed.This is the first complaint opened in the enovis (agile) complaint system since the issuing of capa: car-00728 for evolve34 lapidus correction jigs (3400-06-000 and 3400-06-001) jig knob and carbon fiber material breakage.The legacy trillian/medshape complaints listed below were confirmed complaints for the jig knob breakages and three of the five complaints that were used to open capa: car-00728.The legacy customer complaint report (ccr) information and evaluation documents for the legacy complaints are attached to provide further details on each legacy complaint.Ccr 23-12-013: evolve34 correction jig knob reported to snap off after first initial turn by user during im reduction.Ccr 24-01-013: evolve34 lapidus correction jig reported to have the compression knob break off when compressing in surgery.Ccr 24-02-006: evolve34 lapidus correction jig reported to have the compression knob break off when compressing in surgery.Confirmed the 3400-06-000 lapidus correction jig, right device has a correction knob separated from the jig, compression screw is jammed, and the distraction knob/screw gets stuck/jammed.The root cause is being addressed in an existing, open capa: car-00728.No new capa is required.This complaint will become the parent case as it captures the three legacy trillian/medshape confirmed jig knob breakage complaint evaluation/investigations that were part of the complaints used to open capa: car-00728 for evolve34 lapidus correction jigs (3400-06-000 and 3400-06-001) jig knob and carbon fiber material breakage.
Additional Manufacturer Narrative
This supplemental has been created to update section h6.If additional reporting on this event is provided as a supplemental report to this document.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: LAPIDUS CORRECTION JIG, RIGHT
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside dr. nw; suite 440; atlanta GA 30318
• Manufacturer (Section G): MEDSHAPE, INC.; 1575 northside dr. nw; suite 440; atlanta GA 30318
• Manufacturer Contact: stacey bonnell ; 1575 northside dr nw; suite 440; atlanta, GA 30318 ; 4847879764
• MDR Report Key: 21074520
• Report Number: 3007593722-2024-00018
• Device Sequence Number: 8386557
• Product Code: FZX
• UDI-Device Identifier: M9703400060000
• UDI-Public: M9703400060000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2025

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
• Device Catalogue Number: 3400-06-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 05/11/2025; 09/30/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 07/24/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown