MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; DYNANAIL, 10 X 220MM

Catalog Number	1200-01-1022
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
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
Revusion surgery: due to broken implant, pain.
Additional Manufacturer Narrative
See h5, h6, and h11.This complaint was initiated by a report of a dynanail (10x22mm) that was originally implanted on (b)(6) 2025 and due to the device breaking underwent a revision removal surgery in which the nail was removed.The reporter stated that the case and first post-op looked great, but then the patient was having pain and the x-ray done by the clinic revealed that the nail was broke.The reporter sent x-ray images and returned the nail for investigation and evaluation which confirmed the failure mode of device breakage/crack.The dynanail risk analysis matrix document was reviewed.Nail body breaks / bends has a worst-case detection level 2, patient severity level 3, device severity level 3, and occurrence level 1.Multiple cause for the nail breaking exist including material failure, excessive forces placed on the nail, and non-union of the bone.These can occur from pre-fusion weight bearing, long term non-union, or manufacturing/material defects.It is unknown if the surgical technique was adhered to with the information provided, but there were no reported deviations.A definitive probable root cause remains unknown.Complaint history was reviewed from may 29, 2024 to may 29, 2025, resulting in 2 additional complaints of a dynanail ttc breaking.Note that one of the complaints had non-union along with additional hardware likely impacting union and stress dynamics.Based on a sales volume of 1590 from may 29, 2024 to may 29, 2025, the occurrence level of remote is appropriate.The dynanail risk analysis matrix was generated using the legacy medshape risk management sop.Occurrence level comparison is in alignment with that procedure.The hazard is an anticipated risk within the risk analysis matrix and the current occurrences are within the anticipated threshold.Thus, this is not an indication of a systematic issue necessitating a capa investigation.It will continue to be monitored.Therefore, no further action is needed.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: DYNANAIL, 10 X 220MM
• 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: 22324631
• Report Number: 3007593722-2025-00010
• Device Sequence Number: 9023305
• Product Code: HSB
• UDI-Device Identifier: M97012000110220
• UDI-Public: M97012000110220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1200-01-1022
• Device Lot Number: D0108G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male