DynaNail 2200-29-0000Recalls & reported problems
Medshape, Inc. · FRAME ASSEMBLY, CF, DYNANAIL · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M97022002900000), received between Nov 12, 2024 and Nov 20, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Mechanical Problem2
- Failure to Align1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Mechanical Problem; Mechanical Problem
COMPLAINT - THE FRAME WAS NOT ALIGNED WITH THE NAIL ON THE TWO PROXIMAL SCREWS, SO THE DRILL KEPT HITTING THE NAIL. WE HAD TO PERFECT CIRCLE WITH X-RAY TO GET THE FRAME AND NAIL TO ALIGN.LEADING TO A SIGNIFICANT DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23612874 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT - DYNANAIL TRAY THAT HAD SOME MAJOR ISSUES IN THE CASE. THE OUTER TUBE BRACE WAS WAY TOO TIGHT AND COULD NOT BE PUT ON BY HAND, THE TIBIAL SCREWS ALSO MISSED THE NAIL LEADING TO A SIGNIFICANT DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21973466 ↗MalfunctionNov 12, 2024Mechanical Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Failure to Align; Adverse Event Without Identified Device or Use Problem
COMPLAINT - DYNANAIL JIG MIS-CALIBRATED / NOT ALIGNED AND CAUSED SCREW INSERTION ISSUES. PA SCREW MISSED NAIL AND TIBIAL SCREWS MORE DIFFICULT TO PLACE.PA SCREW MISSED AND NEEDED TO BE REMOVED. PA SCREW ARM LATER DROPPED AND DOC FREE HANDED NEW HOLE. TIBIAL SCREW HOLES DIDN'T LINE UP EITHER." THIS RESULTED IN A 30 MIN DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20670007 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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