NA 2361-5032SRecalls & reported problems
Stryker GmbH · Advanced Locking Screw · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327381566), received between Feb 2, 2023 and Jul 20, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam2
- Positioning Failure2
- Adverse Event Without Identified Device or Use Problem1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Limb Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem
As reported: "Removal surgery was performed due to secondary fracture occurred in the femoral trochanteric region ipsilateral to the site of the implanted nail after bone union was achieved."
Patient problems: Limb Fracture
MAUDE report 25881751 ↗MalfunctionJul 9, 2024Positioning Failure; Material Deformation; Mechanical Jam; Positioning Failure; Material Deformation; Mechanical Jam
ADVANCED LOCKING SCREW GOT STUCK WHEN SURGEON STARTED TO ENGAGE THE CONTRALATERAL CORTEX. THE SCREW HEAD WORN AND COULD NOT BE EXTRACTED. THE PATIENT HAD NO IMPACT .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19703142 ↗MalfunctionFeb 2, 2023Positioning Failure; Mechanical Jam; Positioning Failure; Mechanical Jam
AS REPORTED: "WHILE INSERTING A 32.5MM ADVANCED SCREW INTO THE DISTAL HOLE ON THE PROXIMAL SIDE OF THE 200MM NAIL OF THE T2 ALPHA RETRONAIL, IT GOT STUCK AND THE HEAD FLOATED 8MM AND WAS NOT FIXED BICORTICALLY." THE IMPLANT WAS PLACED AND THE SURGERY WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16282410 ↗
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 STP3.5-400Nuvasive 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.
How reports and recalls are matched · Editorial policy · Report an error on this page