NA 03.043.007SRecalls & reported problems
Synthes GmbH · PROTECTION SLEEVE/TIB FIX/FLEX LONG / NAILS Ø 8-11MM / STER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982298829), received between Nov 18, 2025 and Nov 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SURGEON WAS PUTTING IN 10MM NAIL INTO PATIENT'S TIBIA. UPON INSERTION THE METAL SLEEVE JUST GOT ENGAGED FROM THE PLASTIC AND WENT DOWN TO PATIENT¿S TIBIA. LATER THE METAL SLEEVE WAS PULLED OUT BY THE SURGEON. CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23582572 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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