Harmony 74016465Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885556691984), received between Feb 21, 2023 and Jun 4, 2026 — classified as 12 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (20 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, ONE (1) MIS 3.2 MM X 45 MM RIMMED STERILE PIN BROKE IN THE FEMUR. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIN. THE KNEE ARTHROPLASTY WAS RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402746 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE INTRAOPERATIVELY. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211633 ↗
• InjuryJan 8, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE OFF IN THE PATIENT WHEN DRILLING IT INTO THE 5-1 CUT BLOCK. THE SURGEON HAD TO CREATE A DEFECT TO GET THE PIN OUT AND HAD TO FILL THE DEFECT WITH BONE GRAFT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24013255 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A UNI KNEE SURGERY, WHEN THE DOCTOR DROVE ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE TO SECURE THE CUTTING BLOCK FOR JUK FEMUR THE PIN SNAPPED IN HALF. THE HALF PIECE WAS IMBEDDED IN THE PATIENTS BONE AND WAS FULLY RETRIEVED BY THE SURGEON USING A NEEDLE DRIVER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816251 ↗
• InjuryJul 13, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE OFF, BUT IT WAS LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22491095 ↗
• InjuryMay 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE OFF IN THE PATIENT WHEN IT WAS USED TO SECURE THE 5/1 CUT BLOCK. THE BROKEN PIECE WAS DEEP IN BONE AND LEFT WHERE IT WAS AS DO NOT CAUSE A DEFECT IN THE BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21960371 ↗
• MalfunctionNov 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE IN THE PATIENT, WHEN IT WAS PULLED OUT OF IN ONE CUTTING BLOCK. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY OF 5 MINUTES, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646923 ↗
• InjuryAug 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE INSIDE THE PATIENT WHEN TRYING TO BE REMOVED. PIECE WAS LEFT INSIDE THE PATIENT AND NO SURGERY IS PLANNED TO RETRIEVE IT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20065425 ↗
• InjuryJul 15, 2024Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY DCF AP FEM CUT BLK 4 WAS FIXED WITH MIS 3.2MM X 45MM RIMMED PINS STERILE (SPEED PINS). THEN, AFTER CUTTING THE FEMUR, A SPEED PIN BROKE OFF. THE CUTTING BLOCK WAS STUCK AND IT HAD TO BE BROKEN TO GET IT OFF OF THE FEMUR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. PART OF THE SPEED PIN WAS LEFT IN THE PATIENT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19745464 ↗
• MalfunctionJul 11, 2024Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN DRILLING A SPEED PIN TO SECURE A CUTTING BLOCK, THE HEAD OF A MIS 3.2MM X 45MM RIMMED PIN STERILE FRACTURED AND BECAME STUCK INSIDE A SPEED PIN QK CONNECT ADAPTER. THE PIN FRACTURED IN TWO PIECES, ONE PIECE BECAME STUCK IN THE PIN DRIVER, AND THE OTHER PIECE BECAME STUCK IN THE CUTTING BLOCK AND WAS SUCCESSFULLY REMOVED USING VISE-GRIP. THE PROCEDURE RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727345 ↗
• InjuryJun 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE SNAPPED OFF AND GOT EMBEDDED WITHIN BONE OF PATIENT. THE PIN WAS LEFT INSIDE THE PATIENT SINCE REMOVING IT WOULD HAVE CAUSED TOO MUCH DAMAGE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19477734 ↗
• InjuryMay 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE FRACTURED IN THE TIBIAL BONE. DUE TO SIGNIFICANT BONE LOSS, THE FRAGMENT WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19309037 ↗
• MalfunctionApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE AT THE THREADS, REQUIRING THE USE OF A BROKEN SCREW EXTRACTION SET. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085032 ↗
• MalfunctionApr 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA; ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE SNAPPED IN HALF. A TREPHINE WAS NEEDED TO REMOVE THE BROKEN HALF FROM THE BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028960 ↗
• InjuryMar 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE IN THE PATIENT. THE PATIENT'S BONE WAS VERY HARD. THE HEAD OF THE PIN BROKE OFF AND THE THREADS ARE EMBEDDED IN THE BONE AND WILL NOT BE REMOVED. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18826947 ↗
• InjuryNov 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE OFF, IT WOULD BE DETRIMENTAL TO RETRIEVE. THE SURGEON LEFT THE REMAINING PART OF THE SPEED PIN IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166937 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN EXTRACTING TWO (2) MIS 3.2MM X 45MM RIMMED PIN STERILE IT WAS NOTICED THAT THE TIP BROKE OFF, PIN TIP REMAINS IN PATIENT'S BONE, THEY WERE IRRETRIEVABLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO FURTHER INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18084484 ↗
• MalfunctionApr 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE OFF INTO PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED, AND IF THERE WAS A DELAY. ADDITIONALLY, NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781903 ↗
• MalfunctionApr 18, 2023Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE OFF WHILE SCREWING THROUGH THE BLOCK. THE PIN WAS REMOVED. THE PROCEDURE WAS RESUMED, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16759030 ↗
• InjuryMar 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE MIS 3.2MM X 45MM RIMMED PIN STERILE DEVICE BROKE IN SITU, CAUSING THE SURGEON TO FISH OUT THE REMAINING PIN, OUT FROM THE BONE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH AN S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527339 ↗
• InjuryFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, ONE (1) MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE IN FEMUR CUTTING BLOCK AND WAS RETAINED IN THE PATIENT BODY. PART OF THE PIN WAS RETRIEVED WITH FORCEPS, BUT THE TIP OF THE PIN WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16448581 ↗
• InjuryFeb 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE TIP OF A MIS 3.2MM X 45MM RIMMED PIN STERILE BROKE OFF WHILE DRILLING INTO A 4/1 FEMORAL CUTTING BLOCK. THE DOCTOR DID NOT WANT TO GO DIGGING INTO THE CONDYLE TO RETRIEVE IT SO HE LEFT HALF OF THE PIN EMBEDDED INTO THE CONDYLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16415093 ↗