MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL; DYNANAIL, 10 X 300MM

Catalog Number	1200-01-1030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/18/2024
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
The reason for this revision surgery, the doctor conducted a ttc revision on (b)(6) 2024.The patient's original surgery was in (b)(6) 2023.Dr (b)(6) stated the patient's joints had completely healed but he feared there was now an infection due to the health status of the patient.Dr hirose attempted to remove the dynanail from the patient and was unable to backlap the implant out after removing all screws.Multiple attempts were made using the enovis provided removal tools as well as several other resources at the hospital with no success.The infection was determined to not be into the bone just below the skin.The nail was left in the patient.The ttc removal tool was broken off into the implant, inside the patient, during removal attempts.There were (b)(4) similar complaints identified for dynanail removals.However, only (b)(4) similar complaints are relevant to this event as the others were due to nonunion/patient noncompliance.Dhr review did not occur for the dynanail implant as the part and lot numbers remain unknown.It is unknown if the surgical technique was adhered to do to limited information provided.The dynanail was unable to be removed and remains implanted.Thus, visual inspection and dimensional inspection did not occur.Simulated use testing did not occur.The reporter stated the revision was required due to a possible "infection due to the health status of the patient".The joint was reported as "completely healed" and there was no reported failure with the dynanail assembly.The infection was "determined to not be into the bone just below the skin", but the location of the reported infection remains unknown.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.A second report has been filed for the instrument report number 3007593722-2024-00007.

• Brand Name: DYNANAIL
• Common Device Name: DYNANAIL, 10 X 300MM
• 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: 19767986
• Report Number: 3007593722-2024-00006
• Device Sequence Number: 12956288
• Product Code: HSB
• UDI-Device Identifier: M97012000110300
• UDI-Public: M97012000110300
• 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: 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): 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1200-01-1030
• 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: 07/17/2024
• 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): 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: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Unknown