NA 04.005.542SRecalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 52MM F/IM NAIL-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 10886982086112), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2020 DUE TO NONUNION. THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020, TO TREAT TIBIAL FRACTURE DUE TO A TRAFFIC ACCIDENT. THE IMPLANTS WERE REMOVED WITH THE REGULAR TEST BUT WITHOUT CULTURES. THE SURGERY WAS SUCCESSFUL. THE PATIENT STATUS IS STABLE AND WAS DISCHARGED ON (B)(6) 2020, AND THE LAST CLINIC FOLLOW-UP WAS ON (B)(6) 2021, WITH SATISFACTORY HEALING. THIS REPORT IS FOR (1) UNKNOWN NAIL LOCKING SCREW. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 13970602 ↗
Other Screw, fixation, bone devices
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- 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 STP3.5-350Nuvasive 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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