NA 207.642Recalls & reported problems
Synthes GmbH · 4.0MM CANNULATED SCREW SHORT THREAD/42MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982148254), received between May 27, 2021 and May 27, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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 16, 2026.
Most reported problems
Device problems
- Crack1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2021Crack; Crack
IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE, OPEN REDUCTION AND INTERNAL FIXATION (ORIF) MEDIAL CONDYLE (DISTAL HUMERUS) FRACTURE BEING FIXED WITH 4.0 CANNULATED SCREWS. DURING INSERTION OF CANNULATED SCREW, THREADS CAME UNWOUND FROM THE SCREW. FRAGMENTS WERE REMOVED BUT WITH ADDITIONAL DISSECTION, ADDITIONAL FLOUROSCOPY TIME, ADDITIONAL TOURNIQUET TIME, ADDITIONAL ANESTHESIA TIME, AND PROCEDURE TIME WITH A SURGICAL DELAY OF 40 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE.
Patient problems: Insufficient Information
MAUDE report 11897602 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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