MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL MINI; DYNANAIL MINI, 7 X 130MM

Catalog Number	2600-00-7130
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2026
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 reason.
Additional Manufacturer Narrative
This complaint was opened in response to a reported dynanail mini revision surgery.The representative stated that the revision was done because the distal screw in the metatarsal head was slightly prominent and was thought to be the cause of dehiscence.Rather than replacing the screw, the doctor felt that joints had fused enough to remove the dynanail mini and placed in the staples to retain the compression that he was receiving from the previous implant.The dynanail mini was replaced by these staples.The dynanail mini sample was not returned and visuals of the slightly prominent metatarsal head was not provided.Thus, a complete evaluation and investigation could not be completed, and a probable root cause remains unknown.The dynanail mini risk matrix (risk-fa002-0001: ed-50300-02) rev.A was reviewed and in it, the potential failure of a fixation screw backs out of bone and dynanail mini was recorded and accounted for.The potential cause of failure is that there was insufficient friction of screw threads to bone.Another potential cause of the fixation screw backing out could be attributed to patient non-compliance such as weight bearing before doctor's recommendation or abnormal anatomy, however, with the information provided it is unknown if these were factors as there were no reported deviations.The failure mode is ranked with a detection of 1, patient and device severity of 3 and occurrence of 1.A historical search within the timeframe of (b)(6) 2025 to (b)(6) 2026 revealed that this was the second occurrence (cc-00486793) of this failure mode to this product family.The dynanail mini analysis matrix risk-fa002-0001 rev.A, was generated using the legacy medshape risk management sop, qs-7.1 rev 08.Occurrence level comparison is in alignment with that procedure.The hazard is an anticipated risk within the risk analysis matrix and a single occurrence is not an indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.The hazard is an anticipated risk within the risk analysis matrix and a single occurrence is not an indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.

• Brand Name: DYNANAIL MINI
• Common Device Name: DYNANAIL MINI, 7 X 130MM
• 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: 24254937
• Report Number: 3007593722-2026-00001
• Device Sequence Number: 12878645
• Product Code: HWC
• UDI-Device Identifier: M97026000071300
• UDI-Public: M97026000071300
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/28/2026

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: 2600-00-7130
• Device Lot Number: M0036C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male