N/A StandardRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00810633022047), received between Jul 2, 2020 and May 7, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Sep 27, 2022Open, Classified

   The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

   Z-0101-2023 · Root cause: Error in labeling · FDA record ↗

2. Aug 30, 2022Open, Classified

   Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound

   Z-0008-2023 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING A HAMMERTOE PROCEDURE THE ITEM WAS OPENED, BUT IT LOOKED AS IF THE STAPLE WAS ALREADY DEPLOYED AS THE PLASTIC SHEATH WAS NOT FLUSH WITH THE IMPLANT. THEY ENDED UP USING A K-WIRE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112559 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, SEVERAL PATIENTS HAD DIFFICULTY HEALING INCISION WOUNDS. ONE PATIENT EXPERIENCED THE IMPLANT BACKING OUT. THE IMPLANT IN QUESTION IS HAMMERTOE CCI. THE PATIENT REQUIRED A REVISION SURGERY. IT WAS NOTIFIED ABOUT MULTIPLE INCIDENTS IN ONE CONVERSATION. THERE WASN'T DIALOGUE ABOUT NUMBER OF PATIENTS, BUT IT WAS STATED THAT IT WAS SEVERAL. THE IMPLANT WAS HAMMERTOE CCI IN BOTH SIZES. THIS REPORT IS FOR ONE (1) DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT CAPTURES THE REPORTED SEVERAL PATIENTS, WHILE RELATED COMPLAINT PC-001485735 CAPTURES THE ONE PATIENT WHO EXPERIENCED THE IMPLANT BACKING OUT.

  Patient problems: Insufficient Information

  MAUDE report 18377628 ↗
• InjuryDec 12, 2023Migration; Migration

  IT WAS REPORTED THAT THE SURGEON MENTIONED ON THAT SEVERAL PATIENTS HAD DIFFICULTY HEALING THE INCISION WOUND AFTER SURGERY WITH THE HAMMERTOE CCI. ONE PATIENT EXPERIENCED IMPLANT BACKOUT ON (B)(6) 2023 AND REQUIRED A REVISION SURGERY. THIS REPORT INVOLVES ONE DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES THE SURGEON¿S REPORT OF SEVERAL PATIENTS HAVING BEEN AFFECTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 18310678 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT ON NOV 8, 2023, THE LEG OF THE GUIDE BROKE OFF OF THE HAMMERTOE STAPLE GUIDE, AND THE STAPLE POPPED OFF OF THE INSERTER ON THE KIT. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18242299 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT ON NOV 1, 2023 DURING A FOOT SURGERY, THE 4 HOLE DRILL GUIDE FROM THE DEVICE BROKE WHILE THE SURGEON ATTEMPTED TO SNAP THE GUIDE INTO POSITION DURING SURGERY. THERE WAS NO SURGICAL DELAY AND ANOTHER KIT WAS OPENED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR DPS HAERTOE CCI LRG KIT 1.60 K-WIRE/ S FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210016 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES REPRESENTATIVE VISITED SURGEON TO SEE WHY SURGEON HAS NOT USED THE PRODUCTS IN A COUPLE MONTHS. THE SURGEON USED THE HAMMER TOE CCI ROUGHLY FIVE (5) OR SIX (6) TIMES IN A TWO (2) MONTH PERIOD. HOWEVER, THE SURGEON STOPPED BECAUSE IT DID NOT HAVE A GREAT POST OP RESULTS EVEN WITH IDEAL INTER-OPERATIVE VISUALIZATION. ONE WAS LARGE AND OTHER TWO WERE STANDARD SIZES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, TWO (2) OF THE STAPLES HAD BROKEN IN THE FAR CORTEX OF ONE PATIENT. ANOTHER PATIENT¿S PRODUCT JUST FAILED AND THERE WAS A REPORTED NON-UNION. CURRENTLY, THERE IS NO REMOVAL PROCEDURE PLANNED. THIS REPORT INVOLVES ONE (1) DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4) , IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867534 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES REPRESENTATIVE VISITED SURGEON TO SEE WHY SURGEON HAS NOT USED THE PRODUCTS IN A COUPLE MONTHS. THE SURGEON USED THE HAMMER TOE CCI ROUGHLY FIVE (5) OR SIX (6) TIMES IN A TWO (2) MONTH PERIOD. HOWEVER, THE SURGEON STOPPED BECAUSE IT DID NOT HAVE A GREAT POST OP RESULTS EVEN WITH IDEAL INTER-OPERATIVE VISUALIZATION. ONE WAS LARGE AND OTHER TWO WERE STANDARD SIZES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, TWO (2) OF THE STAPLES HAD BROKEN IN THE FAR CORTEX OF ONE PATIENT. ANOTHER PATIENT¿S PRODUCT JUST FAILED AND THERE WAS A REPORTED NON-UNION. CURRENTLY, THERE IS NO REMOVAL PROCEDURE PLANNED. THIS REPORT INVOLVES ONE (1) DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE. THIS IS REPORT X OF 2 FOR (B)(4). THIS PRODUCT COMPLAINT (B)(4) IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867515 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SALES REPRESENTATIVE TRIED TO USE THE NEW PRODUCT COMPLIANT FEATURE BUT COULDN¿T SEND A PHOTO. THE SALES REPRESENTATIVE VISITED THE SURGEON TO SEE WHY THE SURGEON HAD NOT USED THE PRODUCTS IN A COUPLE MONTHS. THE SURGEON USED THE HAMMER TOE CCI ROUGHLY 5 OR 6 TIMES IN A 2-MONTH PERIOD. HOWEVER, I STOPPED BECAUSE HE DID NOT HAVE GREAT POST-OP RESULTS, EVEN WITH IDEAL INTER-OPERATIVE VISUALIZATION. ONE WAS LARGE, AND THE OTHER TWO WERE STANDARD SIZES. THE PATIENT EXPERIENCED IMPLANT FAILURE WITH ONE IMPLANT. TWO IMPLANTS HAVE BEEN CODED AS NPI BASED ON THE IMAGES AND INFORMATION PROVIDED. THERE IS NO EVIDENCE THAT THE IMPLANTS HAVE BEEN REMOVED. IF ADDITIONAL INFORMATION IS RECEIVED, THE DETERMINATION WILL BE REASSESSED. THIS REPORT IS FOR ONE (1)DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16864607 ↗
• MalfunctionAug 9, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT WOULD NOT FIT THROUGH PLASTIC GUIDE BLOCK. WHEN TRYING TO INSERT DRILL PLASTIC SHAVINGS WERE CREATED. FRAGMENTS GENERATED WERE REMOVED WITHOUT ADDITIONAL INTERVENTION. SURGEON DECIDED TO USE ANOTHER IMPLANT. THERE WAS A SURGICAL DELAY OF 5 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - DRILL BITS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), THIS REPORT IS FOR ONE (1), THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15194462 ↗
• MalfunctionJun 21, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL GUIDE PACKAGED IN THIS STERILE KIT WAS FOR A LARGE CCI STAPLE. SURGEON ENDED UP OPENING A LARGE STAPLE AND USING, THIS WAS WASTED AS OPENED ON STERILE FIELD. IT WASN'T OPTIMAL, BUT IT WORKED. PRODUCT IS NOT SUITABLE FOR RETURN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE(1) DEVICE DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754144 ↗
• MalfunctionFeb 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING A PROCEDURE THE STANDARD HAMMERTOE DID NOT FIT INTO THE DRILLED HOLES. THE LARGE HAMMERTOE FIT'S PERFECTLY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN(10) MINUTES OF SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) DPS HAERTOE CCI STD KIT 1.25 K-WIRE/ -S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515170 ↗
• MalfunctionMay 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A THIRD HAMMER TOE CORRECTION PROCEDURE. UPON INSERTING THE DPS HAMMERTOE KIT THE LEG BROKE ON THE CONTINUOUS COMPRESSION IMPLANTS (CCI) AND THE FRAGMENT BROKE ON THE METATARSAL AS WELL. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DPS HAMMERTOE CCI STD KIT 1.25 K-WIRE/ -S. THIS REPORT IS 1 OF 1 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893986 ↗
• MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE HAMMERTOE CCI DISLODGED FROM THE INSERTER BEFORE THE DEVICE WAS IMPLANTED. SURGEON USED THE NEW HAMMERTOE CCI TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408154 ↗
• MalfunctionMar 1, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE USING THE DEPUY SYNTHES HAMMERTOE CCI STD AN EXTRAORDINARY AMOUNT OF FORCE WAS NEEDED TO DEPLOY THE IMPLANT. THE SURGEON LOST HOLD OF THE INSERTION STICK AND KNOCKED A SKIN RETRACTOR OUT OF THE SURGICAL ASSIST¿S HAND AND ONTO THE FLOOR. THIS NEARLY HAPPENED AGAIN UPON INSERTION OF A SECOND IMPLANT. THE SURGEON COMPLETED THE PROCEDURE BUT HAD COMPLAINED ABOUT THE WAY IN WHICH THE IMPLANT NEEDED TO BE DEPLOYED. NO FRAGMENTS GENERATED. THERE WERE TEN (10) MINUTES OF SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: INSERTION INSTRUMENTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), REDUCTION/RETRACTION/DISTRACTION INSTRUMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395617 ↗
• MalfunctionMar 1, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6), 2021, WHILE USING THE DEPUY SYNTHES HAMMERTOE CCI STD AN EXTRAORDINARY AMOUNT OF FORCE WAS NEEDED TO DEPLOY THE IMPLANT. THE SURGEON LOST HOLD OF THE INSERTION STICK AND KNOCKED A SKIN RETRACTOR OUT OF THE SURGICAL ASSIST¿S HAND AND ONTO THE FLOOR. THIS NEARLY HAPPENED AGAIN UPON INSERTION OF A SECOND IMPLANT. THE SURGEON COMPLETED THE PROCEDURE BUT HAD COMPLAINED ABOUT THE WAY IN WHICH THE IMPLANT NEEDED TO BE DEPLOYED. NO FRAGMENTS GENERATED. THERE WERE TEN (10) MINUTES OF SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: INSERTION INSTRUMENTS(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1), REDUCTION/RETRACTION/DISTRACTION INSTRUMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) DEPUY SYNTHES HAMMERTOE CCI STD KIT W/1.25 K-WIRE/ STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395602 ↗
• MalfunctionJul 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE DRILL GUIDE WITHIN THE TIP OF THE PRODUCT BROKE WHILE TRYING TO USE IT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN FIVE (5) MINUTES. PATIENT WAS STABLE. THIS REPORT IS FOR A DEPUY SYNTHES HAMMERTOE CCI STD KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224070 ↗