HammerLock2 HL2MARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810633021477), received between Sep 28, 2018 and May 7, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE HAMMERLOCK IMPLANT KIT WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10033402 ↗
• MalfunctionApr 15, 2020Break; Break

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HAMMERLOCK 2 IMPLANT KIT WAS BROKEN. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A HAMMERLOCK 2 IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9961940 ↗
• MalfunctionApr 9, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING THE ROUTINE INCOMING INSPECTION OF A LOANER SET IT WAS OBSERVED THAT THE HAMMERLOCK 2 IMPLANT KIT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMERLOCK 2 IMPLANT KIT 15X5MM/10 DEGREES/MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9943385 ↗
• MalfunctionSep 10, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN DATE DURING STANDARD STOCKTAKING IT WAS NOTICED THAT THE IMPLANT IS BROKEN OFF INSERTION HANDLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) HAMMERLOCK 2 IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8982969 ↗
• InjurySep 28, 2018Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON HAD ISSUES WITH A HAMMERLOCK 2 IMPLANT AS IT WOULD PUSH INTO THE PATIENT'S PROXIMAL PHALANX WHEN THE SURGEON ATTEMPTED TO REDUCE THE DISTAL AND PROXIMAL PHALANX OVER THE IMPLANT AND PUSH THE PHALANGES TOGETHER. THE IMPLANT WOULD JUST PUSH IN AND NOT ALLOW THE DISTAL PHALANX TO REDUCE PROPERLY. THE IMPLANT WAS PULLED OUT AND THE SURGEON USED A LARGER SIZED IMPLANT. PROCEDURE OUTCOME AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR A HAMMERLOCK2 IMPLANT 15X5 MM ANGLED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7919682 ↗