HammerLock2 HL2LRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810633021446), received between Apr 5, 2016 and Jun 21, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 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 ARE BROKEN WITHOUT THE PACKAGE BEING OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAERLOCK 2 IMPL KIT 15X7/0 DEG/LRG THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14752875 ↗
• MalfunctionOct 27, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS MALDEN, MA SITE, IT WAS OBSERVED THAT THE HAMMERLOCK IMPLANT WAS MISSING A PIECE. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) HAMMERLOCK(TM) 2 IMPLANT KIT 15 X 7 MM, O DEGREES, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10741277 ↗
• InjuryFeb 5, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A METATARSOPHALANGEAL JOINT ARTHRODESIS ON (B)(6) 2019, AN EXPIRED HAMMERLOCK 2 IMPLANT KIT WAS IMPLANTED IN THE PATIENT. THE ISSUE WAS DISCOVERED WHEN THE CIRCULATING NURSE LOOKED AT THE STICKER FROM THE IMPLANT JUST BEFORE THE PATIENT WOKE UP AND REALIZED THAT IT WAS OUT OF DATE. THE SURGEON IMMEDIATELY REMOVED THE HAMMER LOCK IMPLANT AND REPLACED IT WITH A HAMMERTOE CORRECTION K-WIRE. HE DID NOT IMPLANT ANOTHER HAMMER LOCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 15 MINUTES SURGICAL DELAY. PATIENT WAS GOOD. CONCOMITANT DEVICES: DRILL KIT FOR HAMMER LOCK IMPLANT (PART: DK-H2, LOT: BDK180839, QUANTITY: 1). THIS REPORT IS FOR A HAMMERLOCK 2 IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9670880 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT CAME IN WITH A LARGE HAMMERLOCK (2) IMPLANT INSIDE HER TOE THAT HAD BEEN BROKEN. THE ORIGINAL DATE OF THE IMPLANT WAS ON (B)(6) 2018. THERE WAS NO PLAN OF REMOVING THE IMPLANT. THIS REPORT IS FOR ONE (1) HAMMERLOCK 2 IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856170 ↗
• MalfunctionMar 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TWO (2) HAMMERLOCK 2 IMPLANT ANGLED LARGE BOXES WERE DAMAGED WHICH COULD CAUSE POSSIBLE CONTAMINATION OF THE IMPLANT. THE HAMMERLOCK 2 IMPLANT LARGE AND HAMMERLOCK 2 IMPLANT SMALL HAVE COME OFF THE INSERTER. THE SPEEDTITAN COMPRESSION IMPLANT BROKE THROUGH THE UNKNOWN INSERTER. THE PACKAGES OF THE SPEEDARC COMPRESSION IMPLANT AND SPEEDTRAID IMPLANT SIZING GUIDE WERE DAMAGED AND COULD CAUSE POSSIBLE CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT MEDICAL PRODUCTS REPORTED: UNKNOWN INSERTER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1) THIS REPORT IS FOR ONE (1) HAMM. RLOCK 2 IMPLANT KIT 15X7MM/10 DEGREES/LARGE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420736 ↗
• MalfunctionFeb 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE HAMMERLOCK 2 IMPLANT KIT WAS STILL IN THE STERILE PACKAGE AS THE IMPLANT WAS OFF THE INSERTER PREOPERATIVELY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) HAMMERLOCK 2 IMPLANT KIT 15X7MM/0 DEGREES/LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305343 ↗
• MalfunctionApr 5, 2016Break; Break

  PATIENT UNDERWENT HAMMERTOE CORRECTION PROCEDURE ON (B)(6) 2015. AT 3 WEEKS POST OPERATIVE, X-RAY REVEALED THAT IMPLANT HAD BROKEN. PATIENT HAS NOT REQUIRED REVISION SURGERY, NOR REMOVAL OF BROKEN IMPLANT. IF ADDITIONAL INFORMATION PERTINENT TO THIS INCIDENT IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5548914 ↗