NA 03.043.034SRecalls & reported problems
Synthes GmbH · PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-13MM / STERILE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982298867), received between Apr 14, 2022 and Jun 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Device-Device Incompatibility1
- Material Deformation1
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.
MalfunctionJun 18, 2025Break; Break
IT WAS REPORTED THE METAL CAME OUT OF THE PLASTIC OF THE NAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287674 ↗MalfunctionMay 3, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A PROCEDURE, THE PROTECTION SLEEVE BENT CAUSING THE REAMER/ MEASURING DEVICE TO NOT FIT DOWN, ANOTHER PROTECTION SLEEVE WAS OPENED AND ALSO BENT. THE AIMING ARM BROKE, ANOTHER WAS AVAILABLE FROM THE ACCOUNT TO CONTINUE WITH THE CASE. THE NAIL WAS BACK SLAPPED, AND WHEN TRYING TO PUT IN SCREW 1, THE SECOND AIMING ARM MISSED THE NAIL. PATIENT OUTCOME WAS UNKNOWN. THIS IS REPORT 4 OF 5 FOR (B)(4). THIS REPORT IS FOR PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-13MM / STERILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16860563 ↗MalfunctionApr 14, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE RIA 2 SYSTEM THROUGH THE ADVANCED TIBIA NAIL PROTECTION SLEEVE WAS USED TO COLLECT BONE HARVEST TO TREAT A NON UNION TIBIA SHAFT FRACTURE. WHILE USING THE 11MM RIA 2 REAMER HEAD, UPON PULLING THE REAMER HEAD THROUGH THE PROTECTION SLEEVE IT CAUGHT ON THE METAL INSIDE OF THE INSERTION SLEEVE THUS DESTROYING THE SLEEVE AND RIA 2 DISPOSABLE SHAFT. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14111331 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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