MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; DYNANAIL MINI

Catalog Number	UNKNOWN
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/16/2024
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 dynanail mini removal connection screw/bolt broke x2.
Additional Manufacturer Narrative
The complaint was initiated based on a revision surgery that was completed to remove a two dynanail mini subtalar fusion implants with the use of 2900-24-0250 removal connection screw, m2.5, dynanail mini.From follow-up emails and reports on the case, there was no information provided for the reason of the revision surgery.There was no information provided on the specific part number of the dynanail implant.There was no information provided about patient adverse reactions, abnormal anatomy nor if patient non-compliance had occurred.The parts were discarded at the facility so a complete investigation and evaluation could not be conducted.An x-ray image was provided by the sales representative of the implant before removal.From this image, no conclusive statements could be made about the cause of removal nor the failure of the part.Possible factors for requiring a revision surgery include adverse patient reaction, the screw backing out or a removal in preparation for a different procedure.In reference to the salesforce form completed by the sales representative, it was described that the two removal connection screws broke and needed replacement.The removal connection screws were not returned and so a complete evaluation and investigation could not be conducted on this failure.This failure mode is accounted for in the risk matrix (risk-fa002-0001: medshape ed-50300 risk management, design< dynanail mini).The failure is documented as instrument breaking/bending and is assigned a detection 1, severity 3, and occurrence 1.The potential cause of failure is recorded as strength of instruments not suitable for use.Another possible cause of the removal connection screws' breakage could be attributed to improper removal technique, like attempting to remove the implant with power which could damage the product.However, the probable cause remains undetermined.The risk is accounted for in the matrix and thus is an anticipated hazard.This is an isolated case, and no conclusion could be made regarding what the failure mode was nor what was the cause for the revision surgery.Additionally, no investigation or evaluation could be conducted for the reported removal connection screw breakage.The failures are documented anticipated risks thus; there is no indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: DYNANAIL MINI
• 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: 19956483
• Report Number: 3007593722-2024-00009
• Device Sequence Number: 18339113
• Product Code: HWC
• UDI-Device Identifier: M97026000443380
• UDI-Public: M97026000443380
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/09/2024
• 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