TwinFix 58-30422Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540362124), received between Sep 23, 2020 and Sep 23, 2020 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2020Fracture; Fracture

  PRIMARY PROCEDURE, LEFT SCAPHOID. IT WAS REPORTED THAT THE TWINFIX SCREW COMPLETELY SEATED. ONCE THE HANDLE WAS SET FOR SCREW COMPRESSION, NO COMPRESSION OCCURRED. WHEN EXTRACTION WAS ATTEMPTED, AN ALL-BLUE PORTION OF THE SCREW CAME OUT AND THE REST STAYED IN. IT IS UNKNOWN HOW MUCH (OR IF ALL) OF THE BLUE PORTION BROKE. IT IS UNKNOWN EXACTLY WHEN THE SCREW BROKE (I.E. DURING IMPLANTATION OR DURING ATTEMPTED COMPRESSION). SURGEON PINNED AROUND THE SCREW TO ADDRESS THE FRACTURE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 5-10 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10573204 ↗