SCP® Foot & Ankle Kit 514.302Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024205338), received between Oct 27, 2020 and Dec 2, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Most reported problems
Device problems
- Fracture2
- Patient Device Interaction Problem1
Patient problems
- Foreign Body In Patient2
- Ambulation or Postural Difficulties1
- Loss of Range of Motion1
- Necrosis1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A SUBCHONDROPLASTY, THE CANNULA WOULD NOT ADVANCE DUE TO PATIENT HAVING HARD BONE. IT WAS NOTED SURGEON USED A DRILL BIT TO CREATE A PILOT HOLE BUT CANNULA STILL WOULD NOT ADVANCE AND THE TIP FRACTURED OFF INSIDE OF THE BONE AND WAS RETAINED BY THE PATIENT. NO FURTHER CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15901102 ↗InjuryNov 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Necrosis; Pain
MAUDE report 12729668 ↗InjuryOct 27, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 10740858 ↗
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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