NA 02.226.120Recalls & reported problems
Synthes GmbH · 3.0MM HEADLESS COMPRESSION SCREW-LONG THREAD 20MM · 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 10886982058263), received between Jul 3, 2019 and Jul 3, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
1 other recall cover devices cleared under the same FDA submission (K050636, K161616); they may or may not involve this specific model.
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
- Difficult to Advance1
- Failure to Cut1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 3, 2019Failure to Cut; Difficult to Advance; Failure to Cut; Difficult to Advance
IT WAS REPORTED THAT ON DURING ON AN UNKNOWN PROCEDURE (B)(6) 2019, THE LONG THREAD OF THE HEADLESS COMPRESSION SCREW DID NOT ENGAGE IN THE NEAR CORTEX. THE HEAD WOULD NOT ADVANCE INTO THE BONE AND WAS STILL IN THE JOINT. THE SURGEON REMOVED THE SCREW AND USED A NON-SYNTHES HEADLESS SCREW TO COMPLETE THE SURGERY. IN ADDITION, IT WAS REPORTED THAT THE SILICONE HANDLE BROKE INTO TWO PIECES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF TWENTY TO THIRTY (20-30) MINUTES. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A 3.0MM HEADLESS COMPRESSION SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8760845 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K050636, K161616. One submission often covers many models, so check the product and lot details in each record.
- Z-0238-2019 · Sep 12, 2018 · Terminated3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-
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 STP3.5-350Nuvasive 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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