MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL; REMOVAL TOOL

Catalog Number	2200-14-0000
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was repported that the ttc removal tool was broken off into the implant, inside the patient, during removal attempts.There was one similar complaint identified for a broke dynanail ttc removal tool with a root cause of incorrect surgical technique.There were no abnormalities in regards to dhr review for the removal tool.The damaged removal tool was not returned so visual and dimensional inspection did not occur.Simulated use testing did not occur.The reporter stated the "ttc removal tool was broken off into the implant, inside the patient" and was unable to be removed.As the nail was implanted for approximately 16 months and the reporter stated the joints were completely healed, potential boney ingrowth into nail may have occurred, increasing the force required to remove the dynanail.However, there were no x-rays provided of the construct to confirm and no excessive growth noted.Due to the limited information provided as well as the removal tool not being removed, the root cause shall remain as unknown.
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
Instrument failure - the ttc removal tool was broken off into the implant, inside the patient, during removal attempts.

• Brand Name: DYNANAIL
• Common Device Name: REMOVAL TOOL
• 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
• MDR Report Key: 19779787
• Report Number: 3007593722-2024-00007
• Device Sequence Number: 4148388
• Product Code: LXH
• UDI-Device Identifier: M97022001000000
• UDI-Public: M97022001000000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2200-14-0000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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: Other
• Patient Age: 53 YR
• Patient Sex: Unknown