VARIAX 703690Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327069853), received between Jun 15, 2018 and Jun 11, 2025 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "ITEM 703690 BROKEN AND LEFT IN PATIENT'S BODY DURING SURGERY, NOT RETRIEVED IN THE SURGERY".

  Patient problems: Foreign Body In Patient

  MAUDE report 22183326 ↗
• InjuryDec 3, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "'THE TIP OF THE DRILL BIT BREAKS OFF DURING THE DRILLING PROCESS. THE TIP CANNOT BE RETRIEVED AND REMAINS IN THERE. IT CANNOT BE RULED OUT THAT THIS COULD LEAD TO HARM TO THE PATIENT IN THE FUTURE.''

  Patient problems: Foreign Body In Patient

  MAUDE report 20836495 ↗
• InjuryOct 18, 2024Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "A MEDICAL DEVICE INCIDENT (MDI) WITH HARM HAS BEEN REPORTED." UPDATE OCT (B)(6) AS PER HEALTH CANADA: "DRILL BIT BROKE OFF IN PATIENT'S ARM DURING SURGERY." UPDATE DEC (B)(6): THE PIECE REMAINS IN THE PATIENT AS IT WAS IN A PLACE THAT WOULD HAVE BEEN DIFFICULT TO GET TO; NO ATTEMPTS WERE MADE TO REMOVE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20484506 ↗
• MalfunctionJan 25, 2023Break; Fracture; Break; Fracture

  CUSTOMER CONTACTED US FOR A WICK THAT HAS BEEN BROKEN. IT IS UNKNOWN IF DEBRIS WAS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16240002 ↗
• MalfunctionJul 19, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL REF 703690 BROKE DURING MEDICAL PROCEDURE. THE PART WAS LEFT INTO PATIENT BODY. PATIENT RETURNED TO HOSPITAL REQUESTING THE POSSIBILITY TO UNDERGO MRI WITH THE DRILL INSIDE A BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 15059949 ↗
• MalfunctionJun 15, 2018Break

  IT WAS REPORTED BY THE DISTRIBUTOR THAT SURGEON PERFORM DRILLING WITH 2.0 DRILL BIT AND IT WAS BROKEN. SURGEON ASKED FOR THE SAME SAID DRILL BIT AND PERFORMED SECOND DRILLING, AND IT WAS BROKEN AGAIN. X-RAY SHOWED THE DRILL BITS WERE BROKEN IN THE BONE AND DRILL BITS WERE NOT REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7606385 ↗
• MalfunctionJun 15, 2018Break

  IT WAS REPORTED BY THE DISTRIBUTOR THAT SURGEON PERFORM DRILLING WITH 2.0 DRILL BIT AND IT WAS BROKEN. SURGEON ASKED FOR THE SAME SAID DRILL BIT AND PERFORMED SECOND DRILLING, AND IT WAS BROKEN AGAIN. X-RAY SHOWED THE DRILL BITS WERE BROKEN IN THE BONE AND DRILL BITS WERE NOT REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606384 ↗