Cannulated Compression Headless Screw 04.334.240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917023749), received between May 29, 2020 and Mar 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• MalfunctionMar 1, 2021Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON IS PERFORMING A HAND CASE USING OUR CANNULATED COMPRESSION HEADLESS SCREWS. THE HEAD OF ONE OF THE SCREWS BROKEN OFF DURING THE SURGERY THE REST OF THE SCREW REMAINS INSIDE THE FINGER AND THEN DISCARDED THE HEAD OF THE SCREW INTO THE GARBAGE WHILE TALKING TO THE PHYSICIAN WE THINK IT WAS STUCK IN AN UNKNOWN K-WIRE AND BEING ENTERED AND FORCE PUTTING THE SCREW ON TOP OF THE SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - GUIDE/COMPRESSION/K-WIRES: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 11392443 ↗
• MalfunctionMay 29, 2020Fracture; Fracture

  "IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF METACARPAL 3, 4, 5 DUE TO A MAL-UNION + NON-UNION FROM THE PREVIOUS PINNING. DURING THE PROCEDURE, ONE (1) TITANIUM CANNULATED COMPRESSION HEADLESS SCREW BROKE DURING INSERTION INTO THE 4TH METACARPAL. THE HEAD PORTION OF THE SCREW STUCK ON THE SCREWDRIVER FOR REMOVAL. THE SURGEON USED SCREW REMOVAL CONICAL TOOL + NEEDLE HOLDER TO BREAK OFF SECTIONS OF THE SCREW SHAFT. HALF OF THE SCREW WAS REMOVED WITH DIFFICULTY AND THE OTHER HALF OF THE SCREW REMAINED INSIDE THE 4TH METACARPAL. THE PROCEDURE WAS CONTINUED BY PLACING AN ALTERNATE PLATE TO FIX FRACTURE AROUND THE BROKEN SCREW SEGMENT. ONE (1) CORTEX SCREW SELF-TAPPING HEAD BROKE OFF DURING INSERTION. THE SCREW HEAD REMAINED ON THE SCREWDRIVER AND THE SCREW SHAFT WAS REMOVED EASILY WITH NEEDLE HOLDER. TWO (2) STARDRIVE SCREWDRIVER SHAFT SELF RETAINING HEX COUPLING WAS STRIPPED ON SCREW INSERTION AND ONE (1) STARDRIVE SCREWDRIVER SHAFT SELF RETAINING HEX COUPLING BROKE ON SCREW INSERTION. ALL PARTS OF THE BROKEN STARDRIVE SCREWDRIVER SHAFT SELF RETAINING HEX COUPLING WERE EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10101291 ↗