SMALL CANNULATED SCREWS 71102282SRecalls & reported problems
Smith & Nephew, Inc. · 2.0MM QFX SCREW 12MM STERILE · Class 2 · Implant
All models of SMALL CANNULATED SCREWS (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010623409), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Fracture; Separation Failure; Fracture; Separation Failure
IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, USING A 2.0MM QFX SCREW 12MM TO FIXATE A DISTAL METATARSAL OSTEOTOMY, UPON INSERTION A SIDE TO SIDE ROCKING MOTION WAS APPLIED TO ATTEMPT TO GET THE SCREW TO SNAP OFF THE DRIVER INSERTER PORTION BUT RATHER THAN 'SNAPPING OFF' AS THEY ARE SUPPOSED TO, IT REMAINED ATTACHED TO THE PIN DRIVER. THIS FORCE CAUSED THE SCREW TO BREAK THROUGH THE DORSAL CORTEX OF THE BONE WHICH LED TO LOSS OF FIXATION. THE FRACTURED SCREW WAS REMOVED. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22710831 ↗
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- PRECICE® Plating System LP4.5-MRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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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