NA 04.005.564SRecalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 74MM F/IM NAIL-STER · 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 10886982086334), received between Sep 1, 2020 and Sep 1, 2020 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Failure of Implant2
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2020Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE, TWO LOCKING SCREWS OF THE RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) NAIL WERE BROKEN. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: RAFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 74MM F/IM NAIL-STER (PART # 04.005.564S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 74MM F/IM NAIL-STER. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 10478252 ↗InjurySep 1, 2020Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE, TWO LOCKING SCREWS OF THE RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) NAIL WERE BROKEN. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: RAFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 74MM F/IM NAIL-STER (PART # 04.005.564S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 74MM F/IM NAIL-STER. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 10478245 ↗
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- 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.
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