NA 207.730Recalls & reported problems
Synthes GmbH · 4.0MM CANNULATED SCREW LONG THREAD/30MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982148452), received between Aug 13, 2019 and Dec 30, 2025 — classified as 1 injury, 1 malfunction.
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
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED ON (B)(6) 2025 THAT DURING A SURGERY, WHILE IMPLANTING A 4.0 CANNULATED SCREW IN THE PATIENT¿S DISTAL TIBIA, THE SCREW BROKE. THE SURGEON WAS FINISHING IMPLANTING THE SCREW AND WE NOTICED A FRAGMENT OF THE SCREW BROKE OFF INTO THE PATIENT. WE REMOVED THE SCREW AND WERE UNABLE TO REMOVE THE FRAGMENT. ONCE REMOVED, IT APPEARED TO BE THE LAST THREAD OF THE SCREW THAT BROKE OFF.
Patient problems: Foreign Body In Patient
MAUDE report 23924277 ↗InjuryAug 13, 2019Break; Break
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, A CANNULATED SCREW LONG THREAD WAS BROKEN WHEN THE SURGEON TRIED TO REMOVE IT FOR ANOTHER SIZE SCREW. THE BROKEN SCREW FRAGMENTS WERE RETAINED IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 4.0MM CANNULATED SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8887571 ↗
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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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