NA 04.043.030SRecalls & reported problems
Synthes GmbH · TIBIAL NAIL-ADVANCED / 8MM 330MM / STERILE · Class 2 · Implant
Data updated Oct 16, 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 10886982297471), received between Dec 15, 2023 and Dec 15, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K201336); they may or may not involve this specific model.
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
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, WHILE THE SURGEON WAS ATTEMPTING TO DRILL THROUGH SLEEVES AND THE PROXIMAL STATIC 1 HOLE ON THE NAIL IN QUESTION, THE DRILL BIT HIT THE NAIL. AS A RESULT, THE DRILL BIT WOULD NOT PASS THROUGH, RESULTING IN ONLY 1 SCREW BEING PLACED PROXIMALLY IN THE PROXIMAL STATIC 2 HOLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 10 MINUTES. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 8MM 330MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4) .
Patient problems: Insufficient Information
MAUDE report 18335047 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201336. One submission often covers many models, so check the product and lot details in each record.
- Z-0228-2026 · Sep 26, 2025 · Open, ClassifiedLOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva
- Z-0229-2026 · Sep 26, 2025 · Open, ClassifiedLOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 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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