TwinFix 58-30424Recalls & reported problems
Stryker GmbH · CANNULATED COMPRESSION SCREW · 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 04546540362148), received between Apr 8, 2021 and Apr 8, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionApr 8, 2021Fracture; Fracture
IT WAS REPORTED THAT IN USING THE TWINFIX SCREW TO REDUCE A LEFT SCAPHOID FRACTURE, THE SURGEON FELT THE SCREW MAY HAVE BEEN DRIVEN TOO FAR. WHEN THE SURGEON ATTEMPTED TO BACK THE SCREW UP, THE PROXIMAL (BLUE) PORTION WAS PULLING AWAY FROM THE DISTAL (GOLD) PORTION. THE PROXIMAL PORTION WAS REMOVED AND THE DISTAL PORTION DRIVEN THROUGH AND REMOVED FROM THE DISTAL SIDE. A SECOND SCREW WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 1-HOUR SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11636100 ↗
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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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