NA 04.045.064TSRecalls & reported problems
Synthes GmbH · LOCKING SCREW FOR IM NAIL Ø 5.0MM / L 64MM / XL25/ STER · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10886982302793), received between Jan 26, 2026 and Jan 26, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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. 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
- Migration1
Patient problems
- Discomfort1
- Pain1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 26, 2026Migration
PATIENT WITH DISTAL FEMUR FRACTURE WAS TREATED WITH RETROGRADE FEMORAL NAIL ON (B)(6) 2025. PATIENT REPORTED DISCOMFORT (PAIN/TISSUE IRRITATION) IN DISTAL FEMUR IN EARLY 2026,. FOLLOW UP X-RAYS SHOW SCREW BACK OUT OF DISTAL OBLIQUE SCREWS. 0MM END CAP WAS USED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. A LATERAL ATTACHMENT WASHER WAS IMPLANTED. ALL DISTAL IM SCREWS WERE REMOVED AND ONLY PROXIMAL RETAINED WHICH IS THE SHORTER SCREW.
Patient problems: Discomfort; Pain; Skin Inflammation/ Irritation
MAUDE report 24183469 ↗
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-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 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE Intramedullary Limb Lengthening System LSB5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 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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