Two-Step Hammertoe 204-30-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812926021942), received between Apr 9, 2020 and Apr 9, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K122959); they may or may not involve this specific model.

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.

• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE CALLED TO REPORT A REVISION HAMMER TOE CASE THAT OCCURRED WITH DOCTOR 1 AT HOSPITAL 1 ON (B)(6) 2020. ON (B)(6) 2020, DOCTOR 1 WAS ABLE TO BE ON A CONFERENCE CALL WITH THE SALES REPRESENTATIVE AND A TRILLIANT SURGICAL SALES SUPPORT SPECIALIST TO REPORT FURTHER INFORMATION ON THE REVISION. NO X-RAYS WILL BE PROVIDED AT THIS TIME DUE TO THE FACILITY'S STRICT REGULATIONS ON PROVIDING X-RAYS TO OUTSIDE VENDORS. DOCTOR 1 PERFORMED A PROXIMAL INTERPHALANGEAL JOINT (PIP) FUSION ON THE 2ND, 3RD, AND 4TH DIGIT OF A MALE PATIENT, AGE UNKNOWN AT HOSPITAL 1 ON (B)(6) 2020. DOCTOR 1 REPORTED THE PATIENT HAD OKAY BONE QUALITY, UNDERLYING NEUROLOGICAL ISSUES, AND A CAVUS FOOT TYPE. A 3.4 X 3.0 X 8MM HAMMERTOE IMPLANT (204-30-008, LOT TSL006740) WAS IMPLANTED IN THE 2ND AND 3RD DIGIT. A 3.4 X 3.0 X 6MM HAMMERTOE IMPLANT (204-30-006, LOT TSL006454) WAS IMPLANTED IN THE 4TH DIGIT. THE PROCEDURE WENT AS EXPECTED AND DOCTOR 1 LEFT THE K-WIRES FIXATED IN THE 2ND, 3RD, AND 4TH DIGIT AND SENT THE PATIENT HOME IN A WALKING BOOT. ROUGHLY TWO (2) WEEKS POST-OPERATIVE ((B)(6) 2020), DOCTOR 1 SAW THE PATIENT AGAIN FOR A FOLLOW-UP APPOINTMENT. THE PATIE

  Patient problems: Impaired Healing

  MAUDE report 9943361 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122959. One submission often covers many models, so check the product and lot details in each record.

• Z-1610-2020 · Jul 19, 2018 · Terminated
  Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is