N/A LargeRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810633022054), received between Feb 4, 2021 and Apr 24, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionApr 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DPS HAERTOE CCI LRG KIT 1.60 K-WIRE/ S WAS PREMATURELY DEPLOYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988705 ↗
• MalfunctionDec 30, 2024

  HANDPIECE DID NOT RELEASE STAPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034643 ↗
• 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 LRG KIT 1.60 K-WIRE/ S THIS IS REPORT 2 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 18377629 ↗
• MalfunctionAug 27, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021 THE GUIDE BROKE WHEN INSERTING THE HAMMERTOE CCI LARGE. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY SWITCHING TO SMALL HAMMERTOE CCI. NO OTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380557 ↗
• 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 LARGE KIT W/1.60 K-WIRE/ STER. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395519 ↗
• 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 LARGE KIT W/1.60 K-WIRE/ STER. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395503 ↗
• MalfunctionFeb 4, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE USING HAMMERTOE CCI LARGE KIT, THE IMPLANT INSERTER VERY DIFFICULT TO RELEASE. THE PHYSICIAN HAS DONE 8-10 OF THESE CASES AND OUR INSERTER IS NOT RELEASING IMPLANT EASILY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STER. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281540 ↗