NA 02.226.027Recalls & reported problems
Synthes GmbH · 3.0MM HEADLESS COMPRESSION SCREW-SHORT THREAD 27MM · Class 2 · Implant
Data updated Oct 16, 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 10886982058003), received between Mar 5, 2021 and Mar 5, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionMar 5, 2021Break; Break
IT WAS REPORTED THAT ON (B)(6) 2021, DURING FOOT SURGERY, PERFORMING A LEFT FIRST MT OSTEOTOMY USING 3.0 HEADLESS COMPRESSION SHORT THREAD SCREW, WHILE INSERTING THE HEADLESS SCREW, THE SURGEON NOTICED SOME DIFFICULTY IN FULLY SEATING THE SCREW HEAD. INTRA OPERATIVELY X-RAY TAKEN IDENTIFIED A PEELING OF THE THREADS OF THE SCREW. THUS, THE SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW. X-RAYS SHOWED EVERYTHING WAS OPTIMAL. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 3.0MM HEADLESS COMPRESSION SCREW-SHORT THREAD 27MM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11424006 ↗
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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