Harmony 74016255Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556746745), received between Feb 24, 2023 and Feb 7, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE CLIP OF ONE (1) STD FLEXION BLOCK BROKE. THE PROCEDURE WAS COMPLETED WITHOUT 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 21339940 ↗
• MalfunctionFeb 5, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE LEFT SIDE OF ONE (1) STD FLEXION BLOCK IS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317702 ↗
• MalfunctionOct 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) STD FLEXION BLOCK FRACTURED AT THE BUMPER WHERE THE HANDLE CONNECTS. THE BROKEN PIECES THAT FELL INTO THE PATIENT WERE ALL RETRIEVED AND ACCOUNTED FOR USING A TONSIL INSTRUMENT. THE PROCEDURE RESUMED WITHOUT ANY DELAY, BY MOVING FORWARD WITHOUT PERFORMING THE FLEXION GAP ASSESSMENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418283 ↗
• MalfunctionMay 21, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, ONE (1) STD FLEXION BLOCK BROKE IN-OPERATIVELY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NOTHING WAS LEFT IN THE PATIENT AND NO PATIENT INJURIES HAVE BEEN REPORTED UP TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359905 ↗
• MalfunctionMay 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, ONE (1) STD FLEXION BLOCK BROKE UPON USING. NO OBJECTS FELL INTO THE PATIENT AND ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353007 ↗
• MalfunctionMar 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE END CAPTURE OF THE MEDIUM HEXDRIVER LEFT LIP ABOVE THE CONNECTION POINT OF THE STD FLEXION BLOCK WAS NOTICED TO BE SHEARED OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913898 ↗
• MalfunctionMar 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE CHECKING THE FLEXION GAP, THE THIN PIECE OF PLASTIC, AT THE JUNCTION WHERE THE PUSH BUTTON ENTERS THE FLEXION GAP STICK, OF A STD FLEXION BLOCK BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16558332 ↗
• MalfunctionMar 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE CHECKING THE FLEXION GAP, THE THIN PIECE OF PLASTIC, AT THE JUNCTION WHERE THE PUSH BUTTON ENTERS THE FLEXION GAP STICK, OF A STD FLEXION BLOCK BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16556614 ↗
• MalfunctionFeb 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHILE CHECKING THE FLEXION GAP, THE THIN PIECE OF PLASTIC, AT THE JUNCTION WHERE THE PUSH BUTTON ENTERS THE FLEXION GAP STICK, OF A STD FLEXION BLOCK BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439987 ↗