HammerLock2Recalls & reported problems across all models
Synthes GmbH · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 5 models of HammerLock2 by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2016 and Jun 21, 2022 — classified as 6 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Break” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported HammerLock2 problems
Device problems
- Break11
- Appropriate Device Problem Term/Code Not Available3
- Device-Device Incompatibility3
- Detachment of Device or Device Component2
- Difficult to Open or Close1
- Improper or Incorrect Procedure or Method1
- Material Twisted/Bent1
- Packaging Problem1
Patient problems
- No Code Available6
- No Consequences Or Impact To Patient6
- No Patient Involvement5
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
HammerLock2 models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HammerLock2 HL2LPin, Fixation, Smooth7 reports
- HammerLock2 HL2MAPin, Fixation, Smooth5 reports
- HammerLock2 HL2SPin, Fixation, Smooth4 reports
- HammerLock2 HL2LAPin, Fixation, Smooth3 reports
- HammerLock2 HL2MPin, Fixation, Smooth1 report
Recent HammerLock2 adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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. CONCOMI
Patient problems: Failure of Implant; No Code Available
MAUDE report 10449304 ↗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 ↗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 ↗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 ↗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 ↗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, 2019Packaging Problem; Packaging Problem
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 SPEED TITAN 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 DEVICE REPORTED: UNKNOWN INSERTER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS REPORT IS FOR ONE (1) HAMMERLOCK 2 IMPLANT KIT 15X7MM/10 DEGREES/LARGE. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8420857 ↗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 28, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HAMMERLOCK 2 IMPLANT ANGLED LARGE WAS DISCOVERED BROKEN INSIDE THE PACKAGE. THE PACKAGE WAS NEVER OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8379325 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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