DynaNail 1200-01-1022Recalls & reported problems
Medshape, Inc. · DYNANAIL, 10 X 220MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M97012000110220), received between Jul 18, 2019 and Apr 22, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Break1
- Fracture1
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain2
- Failure of Implant1
- Pain1
- Patient Problem/Medical Problem1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Patient Device Interaction Problem
REVISION SURGERY DUE TO FAILED IMPLANT.
Patient problems: Insufficient Information; Pain
MAUDE report 24958574 ↗InjuryJun 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
REVUSION SURGERY: DUE TO BROKEN IMPLANT, PAIN.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 22324631 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY; DUE TO UNKNOWN REVISION REASON.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 20488364 ↗InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REVISION REASON.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 20488362 ↗InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 4/9 DR REMOVED THE ABOVE NAIL DUE TO THE PATIENT HAVE SEVERE PAIN IN HIS TIBIA ABOVE THE NAIL. THERE WAS NO STRESS FRACTURE OR ANY DEFECT IN THE BONE VISIBLE VIA XRAY SO DR FLINT DID NOT KNOW WHAT WAS CAUSING THE PAIN. DR WAS NOT CONCERNED WITH THE EFFECTIVENESS OF OUR NAIL AS THE TTC JOINTS HAD HEALED PERFECTLY. THIS NAIL WAS PUT IN APPROXIMATELY 12 MONTHS AGO. DR DECIDED TO SPAN THE ENTIRE TIBIA WITH A SUPRA PATELLAR TIBIAL NAIL FROM STRYKER AFTER REMOVING OURS. IMPLANTS WERE NOT ABLE TO BE OBTAINED AS HOSPITAL POLICY IS TO DISCARD.
Patient problems: Implant Pain
MAUDE report 19235504 ↗InjuryJul 18, 2019Fracture; Fracture
MEDSHAPE WAS NOTIFIED REGARDING A PATIENT WHO EXPERIENCED A FRACTURE OF A DYNANAIL POST-IMPLANTATION.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8804379 ↗
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- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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