VARIAX 703822Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540703774), received between Oct 30, 2018 and Feb 21, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "BROKEN TIP OF BONE GRASPING FORCEPS". THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY. THE BROKEN TIP COULD BE RETRIEVED FROM THE PATIENT'S BODY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437518 ↗
• MalfunctionAug 28, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE BONE GRASPING FORCEPS WAS BROKEN WHEN USED TO REPAIR THE FRACTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633403 ↗
• MalfunctionApr 11, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE INSTRUMENT BROKE THE TIP DURING SURGERY, THE FRAGMENT WAS REMOVED AND DISCARDED AT THE HOSPITAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715460 ↗
• MalfunctionSep 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY TO ADDRESS A RIGHT ANKLE FRACTURE, THE TIP OF THE CLAMP SNAPPED OFF IN THE PATIENT'S BONE. THE PIECE WAS RETRIEVED AND INTRA-OP X-RAY WAS USED TO ENSURE NO PIECES REMAINED IN THE PATIENT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10525199 ↗
• MalfunctionMay 15, 2020Fracture; Fracture

  AS REPORTED: "DOCTOR CLAMPED DOWN ON FRAGMENT AND ONE OF THE ARMS OF THE CLAMP SNAPPED OFF."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10062228 ↗
• MalfunctionOct 21, 2019Break; Fracture; Fracture

  BOTH POINT TO POINT FORCEPS ON THE VARIAX 2 FOOT AND ANKLE TRAY BROKE. THE BROKEN PIECES WERE REMOVED AND AN X-RAY CONFIRMED THEY WERE NO LONGER PRESENT IN THE PATIENT. THE SURGEON WAS AWARE AND CONTINUED THE CASE USING A HOSPITAL ALTERNATIVE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216228 ↗
• MalfunctionOct 21, 2019Break; Fracture; Fracture

  BOTH POINT TO POINT FORCEPS ON THE VARIAX 2 FOOT AND ANKLE TRAY BROKE. THE BROKEN PIECES WERE REMOVED AND AN X-RAY CONFIRMED THEY WERE NO LONGER PRESENT IN THE PATIENT. THE SURGEON WAS AWARE AND CONTINUED THE CASE USING A HOSPITAL ALTERNATIVE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9216224 ↗
• MalfunctionOct 31, 2018Break

  DURING REDUCTION OF CLAVICLE USING STRAIGHT REDUCTION CLAMP, THE TIP OF THE CLAMP WAS BROKEN OFF. THE BROKEN PIECE OF THE CLAMP FELL OUTSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER CLAMP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8025156 ↗
• MalfunctionOct 30, 2018Break; Detachment of Device or Device Component

  DURING REDUCTION OF CLAVICLE USING STRAIGHT REDUCTION CLAMP, THE TIP OF THE CLAMP WAS BROKEN OFF. THE BROKEN PIECE OF THE CLAMP FELL OUTSIDE THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER CLAMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8021012 ↗