MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; FRAME ASSEMBLY, CF, DYNANAIL

Catalog Number	2200-29-0000
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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
Complaint - dynanail jig mis-calibrated / not aligned and caused screw insertion issues.Pa screw missed nail and tibial screws more difficult to place.Pa screw missed and needed to be removed.Pa screw arm later dropped and doc free handed new hole.Tibial screw holes didn't line up either." this resulted in a 30 min delay in surgery.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: FRAME ASSEMBLY, CF, DYNANAIL
• 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: 20670007
• Report Number: 3007593722-2024-00017
• Device Sequence Number: 12819976
• Product Code: HSB
• UDI-Device Identifier: M97022002900000
• UDI-Public: M97022002900000
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2200-29-0000
• Device Lot Number: 01701-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 08/13/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown