NA 458.946Recalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW 46MM- FOR IM NAILS · Class 2 · Implant
Data updated Oct 16, 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 10886982230911), received between Mar 4, 2019 and Jun 14, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Slipped1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) AFTER THE LOSS OF REDUCTION IN SUBTROCHANTERIC FRACTURE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(4) 2019. THE REMOVED DEVICES WERE THE FOLLOWING; ONE (1) DEGREE TITANIUM CANNULATED TFNA, ONE (1) TITANIUM LOCKING SCREW 46MM, ONE (1) TITANIUM LOCKING SCREW 50MM AND ONE (1) TFNA FENESTRATED HELICAL BLADE. PATIENT WAS REVISED TO A NEW NAIL. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. THIS IS REPORT 2 OF 4 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8699419 ↗InjuryMar 4, 2019Device Slipped; Device Slipped
IT WAS REPORTED THAT ON AN (B)(6) 2018, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) NAIL BROKE AT THE PROXIMAL HELICAL BLADE JUNCTION. IT WAS REMOVED AND WAS REPLACED WITH A COMPETITORS HARDWARE. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2017. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. X-RAY REVIEW WAS CONDUCTED: X-RAYS TAKEN AT 2 MONTHS SHOWS LOOSENING/MIGRATION OF DISTAL INTERLOCKING SCREW. CONCOMITANT DEVICE: TFNA HELICAL BLADE 110MM STERILE (PART # 04.038.310S, LOT # UNKNOWN QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Code Available
MAUDE report 8386641 ↗
Other Screw, fixation, bone devices
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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 13, 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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