HammerLock2 HL2MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810633021460), received between Aug 25, 2020 and Aug 25, 2020 — classified as 1 injury.

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.

• InjuryAug 25, 2020Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A HAMMERTOE CORRECTION ON DIGITS 2-5 THE INSERTER FOR THE HAMMERTOE CCI WOULD NOT RELEASE. THE FIRST INSERTER WAS TRIED AND WHEN IT DID NOT WORK, THE SURGEON DRILLED AGAIN TO MAKE SURE THAT IT WENT ALL THE WAY TO THE DRILL STOP. WHEN DRILLING DID NOT WORK, THE SURGEON LOOKED AT IT ON THE BACK TABLE AND EVENTUALLY MANAGED TO RELEASE THE IMPLANT FROM THE INSERTER. THE SURGEON THEN OPENED ANOTHER IMPLANT BUT THE NEW IMPLANT DID NOT RELEASE EITHER. WHEN THE HAMMERTOE CCI DID NOT WORK, A HAMMERLOCK 2 CCI WAS TRIED. THE SURGEON ATTEMPTED TO USE A MEDIUM HAMMERLOCK IMPLANT ON THE SECOND DIGIT AND SUCCESSFULLY INSERTED THE CCI IN THE PROXIMAL PHALANGE. HOWEVER, THE SURGEON COULD NOT GET THE INTERMEDIATE AND DISTAL PHALANGE UP AND ON THE DISTAL END OF THE CCI. A SMALL HAMMERLOCK IMPLANT WAS TRIED, AND STILL HAD THE SAME RESULTS. THE SURGEON THEN PUT A K-WIRE IN. A SMALL HAMMERLOCK 2 CCI WAS TRIED ON THE SECOND DIGIT BUT HAD THE SAME RESULTS. THE SURGEON THEN PUT K-WIRES IN THE REST OF THE DIGITS. THE SURGEON DECIDED TO USE K-WIRES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMI

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10449304 ↗