Cannulated Compression Headless Screw 04.333.226TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00819917027495), received between Nov 17, 2023 and Nov 29, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• MalfunctionNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DID NOT DEVELOP A SURGICAL SITE INFECTION. HE HAD SOME DELAYED WOUND HEALING RELATED TO THAT TWO CCHS IMPLANTS WERE IMPLANTED, RECEIVED ON THROUGH (B)(4).DR (B)(6) STATED THAT THE PATIENT WAS CURRENTLY HAPPY AND WOULD SEE HIM AGAIN IN 4 WEEKS. IF REVISION SURGERY IS HAPPY, DR (B)(6) WILL REMOVE DRILL FRAGMENT AT THAT TIME. IF NOT, HE HAS STATED THAT HE WILL LEAVE IT WHERE IT IS. X-RAY REVEALED: SCREW HAS MIGRATED SLIGHTLY AND DRILL BIT FRAGMENT IDENTIFIED. THE FRAGMENTS GENERATED ARE FROM AN UNKNOWN DRILL DEVICE NOT MADE AT TYBER MEDICAL.

  Patient problems: Insufficient Information

  MAUDE report 18228801 ↗
• InjuryNov 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PERFORMED AN IPJ FUSION USING CCHS. THIS INSTRUMENT SET USED WAS THE SET ON THE SHELF THAT CONTAINED THE REUSABLE 2.0MM DRILL BIT (310.221). WHEN DRILLING FOR THE SCREW THE DRILL BIT BROKE INTO PIECES. BITS WERE REMOVED AS BEST AS POSSIBLE AND FRESH DRILL BIT WAS USED FROM ANOTHER KIT. SCREW WAS INSERTED SUCCESSFULLY. ON FINAL X- RAYS THERE WAS NOT VISIBLE REMNANTS OF THE BROKEN DRILL BIT. WHEN GUIDE WIRE WAS REMOVED IT WAS IDENTIFIED TO HAVE A SLIGHT BEND TO IT. IF OTHER, DESCRIBE IPJ FUSION LEFT SIDE, WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 30 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? METAL ITEMS WERE REMOVED , WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? NO, IF NO, EXPLAIN: ITEMS WERE REMOVED USING VARIOUS INSTRUMENTS. AS MENTIONED ON FINAL X-RAY NO FRAGMENTS WERE VISIBLE, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE EXTRA TIME AND X-RAYS USING FLUOROSCOPY WERE NEEDED, IS THE PATIENT PART OF A CLINICAL STUDY NO, IP(B)(4)

  Patient problems: Insufficient Information

  MAUDE report 18160464 ↗