HammerLock2 HL2SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810633021484), received between Feb 14, 2019 and Jun 21, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, HAMMER LOCK 2 IMPLANTS WERE BROKEN WITHOUT THE PACKAGE BEING OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAERLOCK 2 IMPL KIT 12X5/0 DEG/SMALL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14752865 ↗
• 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 CONCOMIT

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10449390 ↗
• 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 CONCOMIT

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10449244 ↗
• InjuryFeb 14, 2019Break; Break

  THE PROCEDURE OCCURRED ON (B)(6) 2019. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Code Available

  MAUDE report 8339396 ↗