NA 04.005.562Recalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 72MM FOR IM NAILS · 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 10886982086303), received between Jul 18, 2018 and Jul 18, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
- Impaired Healing1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2018Break; Break
CONCOMITANT DEVICES REPORTED: 10MM CANNULATED RETROGRADE/ANTEGRADE FEMOPRAL NAIL ¿ EX 400MM (04.013.460S, LOT: 5599032, QUANTITY 1), 5.0MM LOCKING SCREW WITH T25 STARDRIVE 48MM FOR IM NAILS (04.005.538, LOT NUMBER UNKNOWN, QUANTITY 1), 5.0MM LOCKING SCREW WITH T25 STARDRIVE 78MM FOR IM NAILS (04.005.568, LOT NUMBER UNKNOWN, QUANTITY 1).
Patient problems: Foreign Body In Patient; Impaired Healing; No Code Available
MAUDE report 7698601 ↗
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- 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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