NA 04.045.366TSRecalls & reported problems
Synthes GmbH · LOW PROF LCKNG SCREW F/IM NAIL Ø 5.0MM / L 66MM / XL25/ STER · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982301062), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Slipped1
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.
InjuryApr 3, 2026Break; Device Slipped
IT WAS REPORTED THAT ON (B)(6) 2026 THE PATIENT UNDERWENT A REMOVAL OF A LOOSE SCREW FROM A TNA. WHEN TAKING OUT THE PROTRUDING SCREW, IT WAS DISCOVERED THAT THE SECOND INTERLOCK WAS BROKEN. THIS WAS A MONTH TO THE DAY AFTER THE SURGERY. THIS COMPLAINT IS REGARDING BOTH PROXIMAL INTERLOCKS BREAKING WITHIN 28 DAYS OF IMPLANTATION. THEY WERE 66 AND 64 MM 5.0 LOW PROFILE ANS 5.0 INTERLOCKING SCREWS. THIS REPORT CAPTURES THE SECOND REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TWO (2) LOOSE/BROKEN PROXIMAL INTERLOCKING SCREWS WHILE RELATED COMPLAINT (B)(4) CAPTURES THE FIRST REMOVAL SURGERY PERFORMED ON (B)(6) 2026 DUE TO NONUNION/MALUNION.
Patient problems: Insufficient Information
MAUDE report 24780215 ↗
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 Adva
- 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
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 STP3.5-375Nuvasive 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 STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.