NA 458.942Recalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW 42MM- FOR IM NAILS · 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 10886982230874), received between Mar 20, 2019 and Feb 11, 2022 — classified as 2 injuries.
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 Problem2
Patient problems
- Bone Fracture(s)1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY. THERE WAS A FRACTURE THAT OCCURRED BELOW THE NAIL. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW 42MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 13518334 ↗InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT UNDERWENT A REVISION PROCEDURE DUE TO A NONUNION OF A PERTROCHANTERIC FRACTURE AND A FRACTURED LONG TITANIUM TROCHANTERIC FIXATION NAIL (TFN) THROUGH THE HELICAL BLADE HOLE DUE TO THE NONUNION. BROKEN IMPLANTS WERE REMOVED WITHOUT EVENT AND THE PATIENT¿S FRACTURE WAS TREATED WITH A 6 HOLE DHS PLATE 140 DEGREE. VIVIGEN FORMABLE-15CC AND NORIAN DRILLABLE-5CC WERE USED IN THE REVISION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT DEVELOPED AN INFECTION AFTER INITIAL SURGERY AND REQUIRED MANY ¿WASHOUTS¿ PRIOR TO THE NONUNION AND NAIL FAILURE. PATIENT'S ACTIVITY LEVEL WAS REPORTED AS AMBULATORY. PATIENT AND SURGERY OUTCOME WERE NOT REPORTED. THIS REPORT IS FOR ONE (1) TI LOCKING SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Code Available; Unspecified Infection
MAUDE report 8437390 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- 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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