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

Catalog Number	1200-01-1022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/25/2024
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
Revision surgery - due to unknown revision reason.
Additional Manufacturer Narrative
The dynanail ttc was explanted (b)(6) 2024.Multiple attempts were made to gather additional information as to the cause for the parts being explanted but no further information was provided.The parts were not returned for analysis.Multiple cause for explant could have occurred including non-fusion, implant component breaks, infection, and pain.The dynanail risk analysis matrix documents dfmea-fa001-0000, rev a, and dfmea-fa001-0001, rev a, were reviewed.Multiple line items/causes are associated with removal/explant of the device with varying degrees of detection, patient/device severity, and occurrence.Complaint history was reviewed from (b)(6) 2024 (1st complaint records in agile) to (b)(6) 2025, resulting in 10 complaints (including this one) of a dynanail ttc explant: two (2) non-compliance, two (2) infection, two (2) unknown, one (1) pain, one (1) non-fusion, one (1) nail break, and one (1) instruments related.Based on a sales volume of 1545 from (b)(6) 2024, to (b)(6) 2025, and multiple potential causes (including non-device related), the occurrence level of remote is appropriate for various failure modes.The dynanail risk analysis matrices dfmea-fa001-0000, rev a, and dfmea-fa001-0001, were generated using the legacy medshape risk management sop, qs-7.1 rev 08.Occurrence level comparison is in alignment with that procedure.The reported explant was not return for investigation so a definitive cause could not be determined.Multiple potential causes for explant are appropriately identified in the product risk analysis matrix.The historical complaint review does not indicate a systemic product issue for any specific cause for explant.

• 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: 20488362
• Report Number: 3007593722-2024-00016
• Device Sequence Number: 3506703
• Product Code: HSB
• UDI-Device Identifier: M97012000110220
• UDI-Public: M97012000110220
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 08/01/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 08/01/2025
• 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: Required Intervention
• Patient Sex: Unknown