TwinFix 07-40221Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540388100), received between Aug 16, 2022 and Aug 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "THE PATIENT HAD AN UNCOMPLICATED SCAPHOID NON UNION. AT EXPLORATION THE FRACTURE WAS VISIBLE BUT STABLE. IT JUST REQUIRED A COMPRESSION SCREW ACROSS THE FRACTURE. THE CASE PROCEEDED WITH NO PROBLEMS AND I INSERTED THE GUIDE-WIRE INTO THE OPTIMAL POSITION. THE SCAPHOID WAS DRILLED - AND ¿TAPPED¿ (HE IS YOUNG AND FIT AND SO THE BONE WAS LIKELY TO BE OF ROBUST QUALITY). ON INSERTING THE SCREW, SHORTLY BEFORE IT REACHED ITS OPTIMAL POSITION, THE TOP SUDDENLY ¿STRIPPED¿. IT WAS THEN IMPOSSIBLE TO ADVANCE OR TO REMOVE THE SCREW AND SO IT HAD TO BE LEFT IN A SUBOPTIMAL POSITION, WITHOUT COMPRESSION AND NOT FULLY ACROSS THE FRACTURE SITE. I THEN CLOSELY INSPECTED THE END OF THE SCREWDRIVER, WITH MAGNIFICATION. IT COULD CLEARLY BE SEEN THAT THE HEXAGONAL EDGES WERE WORN AND ROUNDED OFF, WHICH WAS ENTIRELY THE CAUSE OF THE PROBLEM." UPDATE: "THE SCREW REMOVAL TOOL DOES NOT FIT INTO THE HEAD OF THE SCREW - IT IS TOO BIG. IT HAS NEVER FITTED. THE TOOL CANNOT BE USED. IT IS THE SAME FOR EVERY KIT. THE SCREW COULD NOT BE ADVANCED NOR WITHDRAWN.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237648 ↗