NA 04.015.562SRecalls & reported problems
Synthes GmbH · 5.0MM TI DUAL CORE LCKNG SCREW T25 STRDRV 72MM F/IM NAIL-STE · Class 2 · Implant
Data updated Oct 18, 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 10886982089069), received between Apr 9, 2019 and Apr 9, 2019 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K040762); 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inflammation1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD OPEN REDUCTION AND INTERNAL FIXATION (ORIF) ON AN UNKNOWN DATE IN 2012. ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF A TIBIAL NAIL, LOCKING SCREW 72MM, LOCKING SCREW 40MM, TWO (2) LOCKING SCREW 36MM, AND LOCKING SCREW 46MM DUE TO PARTIAL NON-UNION, DELAYED HEALING, INFLAMMATION AND INFECTION. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS SATISFACTORY. THIS REPORT IS FOR ONE (1) LOCKING SCREW 72MM. THIS IS REPORT 2 OF 6 FOR (B)(4).
Patient problems: Inflammation; No Code Available; Unspecified Infection
MAUDE report 8496519 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.
- Z-2051-2015 · Jun 3, 2015 · TerminatedTITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
- Z-2058-2013 · Nov 2, 2012 · TerminatedSynthes Trauma Nail System. The devices are indication for bone fixation.
Other NAIL, FIXATION, BONE devices
- NA 03.043.024Synthes GmbH · NAIL, FIXATION, BONE234 reports
- NA 03.010.440Synthes GmbH · NAIL, FIXATION, BONE70 reports
- TRIGEN 71676627Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall2 reports
- TRIGEN 71676628Smith & Nephew, Inc. · NAIL, FIXATION, BONE1 recall0 reports
- NA 03.043.018Synthes GmbH · NAIL, FIXATION, BONE33 reports
- TRIGEN 71675383Smith & Nephew, Inc. · NAIL, FIXATION, BONE29 reports
- NA 03.010.441Synthes GmbH · NAIL, FIXATION, BONE27 reports
- NA 03.010.435Synthes GmbH · NAIL, FIXATION, BONE24 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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