PANGEA 542021Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327614541), received between Jun 21, 2024 and Sep 10, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Fracture

  As reported: "A drill bit for the Pangea small frag system broke today during use.The tip of the drill bit was reported and broke off in the patient's bone. Was not removed from patient."

  Patient problems: Foreign Body In Patient

  MAUDE report 50715194 ↗
• InjuryMay 29, 2026Fracture

  THE DRILL BIT BROKE DURING A PANGEA TIBIAL SURGERY. IT BROKE WHEN IT CAME INTO CONTACT WITH THE PLATE ON THE OPPOSITE SIDE DURING A DOUBLE-PLATE PROCEDURE. THE SURGERY WAS COMPLETED WHILE THE TIP OF THE BROKEN DRILL BIT REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25332368 ↗
• InjurySep 22, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "MULTIPLE DRILL BITS BROKE CAUSING SKIVING AND DRILLING LARGER HOLES. A DELAY OCCURRED IN ORDER TO GET ANOTHER DRILL BIT; HOWEVER THE LENGTH OF THE DELAY WAS NOT PROVIDED".

  Patient problems: Perforation

  MAUDE report 23116428 ↗
• MalfunctionJul 8, 2025Break; Fracture; Break; Fracture

  AS REPORTED VIA VOLUNTARY MEDWATCH REPORT: TWO DIFFERENT DRILL BITS USED DURING ORTHOPEDIC SURGERY BROKE IN PATIENT'S BONE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22441305 ↗
• MalfunctionNov 4, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT WHILST THE PATIENT WAS BEING IMPLANTED WITH A PLATE, THE DRILL BIT BROKE OFF INTO THE BONE. SURGEON DECIDED TO LEAVE THE BIT FRAGMENT IN PLACE. THE PROCEDURE WAS COMPLETED, AND PATIENT IS RECOVERING.

  Patient problems: Foreign Body In Patient

  MAUDE report 20604022 ↗
• MalfunctionJun 21, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED: THE SURGEON WAS USING THE 2.5MM DRILL BIT, SKU 542021, AND WHILE HE WAS DRILLING IN THE FAR CORTEX OF THE MEDIAL DISTAL TIBIA, THE DRILL BIT BROKE AT THE JUNCTION OF THE CUTTING FLUTES AND THE SHAFT OF THE DRILL. IT SEEMED THAT THE DRILL BIT WAS TOO FLEXIBLE AND WOULD NOT PENETRATE THROUGH THE CORTEX. FROM THAT FORCE AND CURVATURE OF THE BONE, THE DRILL BIT BROKE AT THE SITE LISTED ABOVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580674 ↗