Paratrooper™ Plantar Plate Repair System P13-000-5016-SRecalls & reported problems
Paragon 28, Inc. · Paratrooper Plantar Plate Repair System, Implant Only Kit- Sterile · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889795118479), received between Jan 25, 2024 and Jan 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
TWO SETS OF THE PARATROOPER SHUTTLE ANCHOR DETACHED FROM THE SHUTTLE STRANDS WHILE THE SURGEON ATTEMPTED TO PULL THE IMPLANT THROUGH THE BONE TUNNEL. THE HOSPITAL'S SUTURE WAS UTILIZED TO SUTURE AND ANCHOR TO THE PLANTAR PLATE. ALL DEBRIS WAS SUCCESSFULLY REMOVED BUT SURGERY WAS DELAYED BY 45 MINUTES. THIS IS REPORT 2 OF 2 FOR THE SECOND SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580395 ↗MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
TWO SETS OF THE PARATROOPER SHUTTLE ANCHOR DETACHED FROM THE SHUTTLE STRANDS WHILE THE SURGEON ATTEMPTED TO PULL THE IMPLANT THROUGH THE BONE TUNNEL. THE HOSPITAL'S SUTURE WAS UTILIZED TO SUTURE AND ANCHOR TO THE PLANTAR PLATE. ALL DEBRIS WAS SUCCESSFULLY REMOVED BUT SURGERY WAS DELAYED BY 45 MINUTES. THIS IS REPORT 1 OF 2 FOR THE FIRST SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580197 ↗
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- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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