NA 458.948Recalls & reported problems
Synthes GmbH · 5.0MM TI LOCKING SCREW 48MM- 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 10886982230935), received between May 17, 2019 and Feb 28, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Arthritis1
- Failure of Implant1
- Nonunion/Delayed-union Bone Fracture1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON REMOVED A TFNA NAIL TO CONVERT THE PATIENT TO A TOTAL HIP. PATIENT WAS IN PAIN AND HAS ARTHRITIS OF HER HIP. ALL TFNA IMPLANTS WERE REMOVED SUCCESSFULLY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW 48MM- FOR IM NAILS. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).
Patient problems: Arthritis; Pain
MAUDE report 13620535 ↗InjuryMay 17, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL OF A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM DUE TO NON-UNION OF THE INTERTROCHANTERIC FRACTURE WHICH WAS ALSO CONVERTED INTO A RIGHT TOTAL HIP. THE DISTAL SCREW WAS BROKEN IN THE NAIL. THE ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2016. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THE PATIENT EXPERIENCED PAIN IN THE HIP. CONCOMITANT DEVICE REPORTED: 11MM/130 DEGREE TI CANNULATED TROCH FIXATION NAIL (PART 456.420S, LOT UNKNOWN, QUANTITY 1); 11.0MM TI HELICAL BLADE 95MM (PART 456.304, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 8621149 ↗
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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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