MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL; DYNANAIL, 10 X 220MM

Catalog Number	1200-01-1022
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to failed implant.
Additional Manufacturer Narrative
Agent reported failure of implant.This complaint was opened on account of a revision surgery due to a non-fusion of a dynanail ttc implant.The sample was not returned as the explanted items were discarded at the facility, additionally no visuals were provided, thus a complete evaluation and investigation could not be conducted.The reported stated that the indication of a necessary revision surgery was patient pain.The report noted that the patient had a major deformity which made it was difficult to get alignment during the case.The surgeons had to take out the medial mal to get the alignment needed for fusion.This is a potential root cause for the failed fusion; however, no definitive root cause of the failure could be confirmed.The potential hazard is identified in risk-fa001-0002 fmeas dynanail ttc rev a.In the ufmea, it is recorded as patient experiences malunion with an effect of minor injury to patient.This potential hazard is ranked with severity of 2 and occurrence of 4.The potential cause of the failure includes use error, patient anatomy, and failure to follow ifu.According to the referenced ifu statement in the ufmea, the dynanail ttc fusion nail is intended to facilitate healing but is not designed to support the patient's body weight in the presence of a delayed union or nonunion of bone.A potential adverse effect of this hazard is loss of fixation in bone attributable to nonunion, osteoporosis and/ or markedly unstable comminuted fractures.It is unknown if the surgical technique was adhered to with the information provided, but there were no reported deviations.A historical search was conducted from the timeframe of (b)(6) 2025 to (b)(6) 2026 and showed that this is the second reported incident of a non-fusion revision surgery within the dynanail ttc product family and without a definitive probable cause or conclusion.The occurrence level percentage was determined from the document 3000.1635 risk management where an occurrence level of 4 has a threshold of greater than 0.1% and less than or equal to 1%.Sales volume of the part in this same timeframe were at 2656 units.The occurrence rate of this failure mode for the year is.075%.The occurrence is within the anticipated threshold.There is no further action needed.The hazard is an anticipated risk within the risk analysis matrix and the current occurrences are within the anticipated threshold.Thus, this is not an indication of a systematic issue necessitating a capa investigation.It will continue to be monitored.Therefore, no further action is needed.

• Brand Name: DYNANAIL
• 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: 24958574
• Report Number: 3007593722-2026-00002
• Device Sequence Number: 10093387
• Product Code: HSB
• UDI-Device Identifier: M97012000110220
• UDI-Public: M97012000110220
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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: D0108B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/22/2026
• 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: C6259; 1200-02-5035 LOT: C6260A; 1200-02-5045 LOT: C6239B; 1200-03-5080 LOT: P0021B
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male