NA 04.045.072SRecalls & reported problems
Synthes GmbH · LOCKING SCREW FOR IM NAIL Ø 5MM/ 72MM/ XL25/ STERILE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982294586), received between Jan 23, 2024 and Jan 23, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 reports).
2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2024Migration; Migration
IT WAS FURTHER REPORTED: THE NAIL WAS IMPLANTED ON (B)(6) 2023. THERE WAS NO ALLEGATION AGAINST THE NAIL. THE 2 DISTAL ML SCREWS BACKED OUT OF THE 2ND AND 3RD SCREW HOLES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BACKED OUT SCREWS WERE EXCHANGED.
Patient problems: Insufficient Information
MAUDE report 18566196 ↗InjuryJan 23, 2024Migration; Migration
IT WAS FURTHER REPORTED: THE NAIL WAS IMPLANTED ON (B)(6) 2023. THERE WAS NO ALLEGATION AGAINST THE NAIL. THE 2 DISTAL ML SCREWS BACKED OUT OF THE 2ND AND 3RD SCREW HOLES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BACKED OUT SCREWS WERE EXCHANGED.
Patient problems: Insufficient Information
MAUDE report 18566193 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201336, K201346. One submission often covers many models, so check the product and lot details in each record.
- 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 A
- 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 A
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 STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page