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	09/19/2024
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 associated list of dynanail ttc parts were 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 returned for analysis.The returned nail, screws, and end cap were inspected by r&d.No abnormalities or defects were identified.Based on no apparent damage to the nail, screws, or end cap and no apparent assembly issue with the nail the most probable cause(s) for the nail removal would be pain or infection.For example, there could have been a systemic infection leading to a precautionary removal of dynanail components.Anecdotally, the complaint stated that the patient's insurance required the implant to be returned.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.The line items associated/related to pain and infection indicate a worst-case detection of 2, patient severity of 4, device severity 1, and an occurrence of 1.Complaint history was reviewed from (b)(6) 2024 (1st complaint records in agile) to (b)(6) 2025, resulting in three other complaints ((b)(4)) of a dynanail ttc explant due to pain/infection.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.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 showed no evidence of product failure upon evaluation.Potential causes of pain or infection are appropriately identified in the product risk analysis matrix.Although pain/infection are the likely causes for this explant, due to lack of information the actual cause is unknown and does not indicate a systemic product issue.

• 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: 20488364
• Report Number: 3007593722-2024-00014
• Device Sequence Number: 11639478
• Product Code: HSB
• UDI-Device Identifier: M97012000110220
• UDI-Public: M97012000110220
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1200-02-5030 LOT: UNKNOWN.; 1200-02-5030 LOT: UNKNOWN.; 1200-02-5045 LOT: UNKNOWN.; 1200-03-5070 LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown