NA 04.005.436SRecalls & reported problems
Synthes GmbH · 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 46MM F/IM NAILS-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 10886982085498), received between Nov 24, 2021 and Nov 24, 2021 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K000089, K103002); 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Physical Asymmetry1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY DUE TO IMPLANTS USED CAUSING THE PATIENT TO LOSE REDUCTION OF THE BONE. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 4.0 TI LCKNG SCR T25 SD 46 F/IM NAILS-S. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).
Patient problems: Physical Asymmetry
MAUDE report 12869411 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K000089, K103002. One submission often covers many models, so check the product and lot details in each record.
- Z-2060-2012 · May 22, 2012 · Terminated4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
- Z-2059-2012 · May 22, 2012 · Terminated4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Mu
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 STP3.5-350Nuvasive 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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