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 Code	Unspecified Infection (1930)
Date of Event	01/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to infection.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See h6 and h11.The dynanail ttc was explanted (b)(6) 2025 due to infection.The exact cause of the infection was not relayed and could have been associated with the original implant or unrelated but the location of the reported infection remains unknown.The parts were not returned for analysis.It is unknown if the surgical technique was adhered to due to limited information provided.As there was no reported deficiency with the dynanail construct, and the infection cannot be definitely attributed to dynanail, the root cause shall remain unknown.The dynanail risk analysis matrix documents 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 mar 1, 2024 (1st complaint records in agile) to feb 28, 2025, resulting in two complaints (including this one) of a dynanail ttc explant due to infection.Based on a sales volume of 1545 from mar 1, 2024, to feb 28, 2025, the occurrence level of remote is appropriate for removal due to infection.The dynanail risk analysis matrices were generated using the legacy medshape risk management sop, occurrence level comparison is in alignment with that procedure.The reported complaint did not indicate any evidence of product failure upon evaluation.Potential causes of revision surgery due to infection are appropriately identified in the product risk analysis matrix.Although the specific cause of the revision surgery was infection, it remains unknow the actual cause of the infection.The failure mode and cause are within the acceptable limits identified in the product risk analysis matrix and there is no indication of a systemic product issue.Therefore, a capa is not justified.

• 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: 21270245
• Report Number: 3007593722-2025-00001
• Device Sequence Number: 8071104
• Product Code: HSB
• UDI-Device Identifier: M97012000110220
• UDI-Public: M97012000110220
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: D0100N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 09/19/2025
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female