TWINFIX 07-40220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540361974), received between Nov 27, 2018 and Jun 13, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2022Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  AS REPORTED: "THE ¿TWIN-FIX¿ SET WAS ON LOAN FROM STRYKER. PRIOR TO THE CASE THE STAFF INFORMED ME THAT THE REPRESENTATIVE HAD NOT ATTENDED TO CHECK THE LOAN INSTRUMENTS AND THAT THEY WERE CONCERNED. THEY THEREFORE ASKED ME TO CHECK THE INSTRUMENTS TO ENSURE THAT NONE WERE MISSING, PRIOR TO SENDING FOR THE PATIENT, WHICH I DID. 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." ADDITIONALLY: THE CHANCES OF UNION HA

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674820 ↗
• MalfunctionNov 27, 2018Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT WHEN THE SCREWDRIVER WAS USED THE INTERNAL BIT WHICH COMES OUT HAD SHEARED OFF SO WAS UNABLE TO BE USED. THE SURGEON USED THE 3MM NEW DEAL AND MANAGED TO GET COMPRESSION. DELAY IN SURGERY WAS 45 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8107641 ↗