VARIAX 705297Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327125252), received between Dec 1, 2018 and Mar 10, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Fracture

  AS REPORTED: "ONE TIP OF THE REDUCTION FORCEPS HAS BROKEN OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559244 ↗
• MalfunctionDec 23, 2025Fracture; Fracture

  AS REPORTED: "THE TIP BROKE OFF WHEN GRASPING THE BONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882686 ↗
• MalfunctionOct 29, 2025Fracture; Fracture

  AS REPORTED: "THE TIP OF THE BONE RETRACTOR FORCEPS BROKE OFF DURING REDUCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23418098 ↗
• MalfunctionJun 30, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE BONE HOLDING FORCEPS BROKE DURING SURGERY. THE TIP WAS MISSING. IT WAS NOT BE FOUND INSIDE THE PATIENT'S BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22363026 ↗
• MalfunctionApr 3, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "TIP DAMAGED DURING USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761763 ↗
• MalfunctionMar 26, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP WAS BROKE OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700193 ↗
• MalfunctionDec 20, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  AS REPORTED, AFTER THE PROCEDURE, THE INSPECTOR CONFIRMED THAT THE RATCHET IS LOOSE AND THAT TIP IS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20995783 ↗
• MalfunctionAug 7, 2024Material Fragmentation; Material Deformation; Material Fragmentation; Material Deformation

  THE FORCEPS WAS DAMAGED AT THE TIP, RESULTING IN A FRAGMENT. THE FRAGMENT WAS REMOVED FROM THE PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929380 ↗
• MalfunctionFeb 12, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "THE INSTRUMENT COULD NOT RESIST THE FORCE TO REDUCE THE BONE AND BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691823 ↗
• MalfunctionJun 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE STRAIGHT REDUCTION CLAMP WAS BROKEN DURING ORIF FOR RIGHT FIBULA FRACTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100279 ↗
• MalfunctionFeb 28, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "TIP OF A POINT TO POINT REDUCTION FORCEP SNAPPED OFF DURING REDUCTION OF A BONE IN A PROCEDURE. TIP WAS RECOVERED AND THE INSTRUMENT WAS PASSED OFF. A DIFFERENT REDUCTION FORCEP WAS USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457337 ↗
• MalfunctionJan 4, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE PRODUCT WAS DAMAGED DUE TO A STRONG PULL WHEN IT WAS USED DURING RESTORATION." UPDATE 12/28/2021: THE TIP OF INSTRUMENT IS BROKEN. OTHER INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 13157823 ↗
• MalfunctionMay 21, 2021Break; Break

  AS REPORTED: "IT MAY HAVE BEEN AN UNREASONABLE FORCE WHEN USING IT. THERE WAS NO DAMAGE TO THE PATIENT, AND THE REASON WAS THAT AN UNREASONABLE FORCE WAS APPLIED". UPDATE APR/28/202: CONFIRMATION THAT TIP OF THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861699 ↗
• MalfunctionMay 7, 2021Break; Break

  IT WAS REPORTED THE TIP OF THE PRODUCT BROKE DURING THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794397 ↗
• MalfunctionMay 4, 2021Break; Break

  THE SURGEON REPORTED THAT WHEN THEY GRABBED THE CLAVICLE WITH THE BONE GRIP, THE TIP BROKE WHEN TRYING TO REDUCE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773450 ↗
• MalfunctionMar 12, 2020Fracture; Fracture

  IT WAS REPORTED, THE TIP OF THE REDUCTION CLAMP WAS BROKEN DURING THE SURGERY. THE BROKEN PIECE WAS TAKEN OUT FROM THE PATIENT¿S BODY AND THE PROCEDURE WAS CONTINUED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826906 ↗
• MalfunctionDec 1, 2018Break

  IT WAS REPORTED THAT THE TIP OF THE REPOSITIONING FORCEPS WAS BROKEN WHEN CRIMPING THE FRACTURE PART DURING OPERATION. THE BROKEN PART WAS REMOVED AND THE SURGEON CONFIRMED THAT THE BROKEN PIECE WAS NOT LEFT IN THE PATIENT BODY ON THE IMAGE. AND THE OPERATION WAS CONTINUED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8122218 ↗