VARIAX 703701Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613154973422), received between Aug 27, 2018 and Jul 17, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2019Break

  CUSTOMER REPORTED TO SALES REP THAT: "THE DRILL BROKE DURING INTERVENTION".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8798928 ↗
• MalfunctionJun 25, 2019Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE TIP OF THE DRILL BIT SNAPPED OFF INTO THE PATIENT WHILE DRILLING A HOLE INTO A VARIAX ELBOW PLATE. THE DRILL GUIDE WAS USED. THE PART OF THE DRILL BIT THAT BROKE WAS REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF SURGICAL DELAY OR ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8732824 ↗
• MalfunctionApr 5, 2019Break; Fracture; Fracture

  DURING A OSTEOSYNTHESIS SURGERY OF THE RIGHT HUMEROUS, 2.0 MM CUTTER REF. 703701 BROKE, IN THE TRAY THERE WERE 2 ITEMS OF THE SAME CODE WITH THE RESPECTIVE LOTS 04470V- 04830V (CUSTOMER CANNOT SAY WHICH IS THE LOT NR.). PART OF THE DEVICE REMAINED IN THE BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8487662 ↗
• MalfunctionDec 1, 2018Break

  IN AN ELBOW SURGERY THE DRILL 703701 WAS BROKEN. THE PART OF THE DRILL LEFT INSIDE THE PATIENT. THE DOCTOR TRY TO GET OUT OF THE PATIENT BUT HE DIDNT CAN TAKE IT OUT. THE BROKEN PART WAS LEFT IN THE MUSCLE OF THE PATIENT, BECAUSE WHEN THE DRILL BROKE THEY INTRODUCE THE SCREW AND BY THE OTHER SIDE OF THE BONE THE BROKEN PART GO OUT THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8121800 ↗
• MalfunctionAug 27, 2018Break

  INSTRUMENT BREAKING DURING THE SURGERY IN CMC ELBOW FRACTURE SURGERY AT (B)(6) 2018. A DRILL BIT (703701, 2.0MM) WAS BROKEN AND LEFT INSIDE THE HUMERUS OF A PATIENT. THE PATIENT'S SON IS VERY EAGER TO FIND OUT THE EXACT NATURE OF MATERIAL THE DRILL BIT IS MADE OF, EXACT "GRADING" AS HE REFERRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7820649 ↗