NA 207.742Recalls & reported problems
Synthes GmbH · 4.0MM CANNULATED SCREW LONG THREAD/42MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982148513), received between Sep 30, 2021 and May 3, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 DURING A ORIF OF THE DISTAL HUMERUS, WHILE INSERTING A 4.0MM STAINLESS STEEL, LONG THREAD, CANNULATED SCREW, OVER A 1.25 MM NON-THREADED GUIDE WIRE, THE SCREW BROKE AT THE POINT WHERE THE THREADS BEGIN ON THE SCREW. THE SCREW WAS HITTING INTO ANOTHER 1.25 MM NON-THREADED GUIDE WIRE THAT WAS BEING USED TO MAINTAIN REDUCTION WHILE THE SCREW WAS BEING INSERTED. THE BROKEN SCREW SET WAS USED TO REMOVE BROKEN SCREW, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 15 MINUTES. THERE WAS GENERATION OF FRAGMENTS BUT REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW LONG THREAD/42MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19238901 ↗MalfunctionSep 30, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, WHILE INSERTING THE CANNULATED SCREW, IT BROKE AT ABOUT THE JUNCTURE OF THE SHAFT OF THE SCREW TOWARDS THE TIP. THERE WAS A DELAY OF FORTY-FIVE MINUTES TO AN HOUR TO REMOVE THE BROKEN SCREW. THIS REPORT IS FOR A CANNULATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12556086 ↗
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- 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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