PANGEA 542020Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327614244), received between Dec 20, 2024 and Sep 16, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Fracture

  It was reported that during a routine left total hip makoplasty the surgeon had finished putting the implants in the patient. He then used a drill bit to pass suture for the initial portion of closure of the hip capsule. Whilst doing this the fluted portion of the drill bit broke off while being used in the patient. An initial search was done for the bit with no results, so x-ray was notified and came to the room. Two shots were taken to assess where the drill bit was located. The surgeon read the x-rays and determined that the broken portion of the drill bit was in the patients left femur. He decided to leave the drill bit in situ as the costs of retrieving it would be greater that the benefits of it being removed. The patients hip was then closed and the surgery was concluded.

  Patient problems: Foreign Body In Patient

  MAUDE report 50792135 ↗
• 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 23116430 ↗
• 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 23116429 ↗
• 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

  MAUDE report 22441318 ↗
• MalfunctionMay 16, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING DRILLING FOR A SCREW. THE BROKEN TIP OF THE DRILL BIT WAS LEFT IN THE BONE. A NEW DRILL BIT WAS USED TO PERFORM THE REST OF THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22037989 ↗
• MalfunctionMar 27, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT PRESENTED TO OPERATING ROOM (OR) FOR REVISION OF TIBIAL HARDWARE. DURING THE PROCEDURE A DRILL BIT BROKE WHILE INSIDE OF THE PATIENT'S BONE. ALL PIECES OF THE BIT WERE REMOVED FROM THE PATIENT AND ACCOUNTED FOR, COLLECTED IN A CUP, AND REMOVED FROM THE SURGICAL FIELD. THE PIECES WERE THEN GIVEN TO MANAGEMENT. PER THE INTRAOPERATIVE X-RAY FILMS, NO FRAGMENTS WERE LEFT INSIDE THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21708512 ↗
• InjuryDec 20, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PRIMARY SURGERY, TWO DRILL BITS BROKE WHILE DRILLING. THE INITIAL BREAKAGE LED TO THE USE OF A BACKUP DRILL, WHICH ALSO BROKE. DESPITE ATTEMPTS TO REMOVE THE BROKEN FRAGMENTS, THE DRILL BITS REMAINED UNRECOVERABLE AND WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED USING ANOTHER DRILL, WITH A DELAY OF TWO MINUTES. NO ISSUES WERE REPORTED WITH THE DRILLS THEMSELVES BEFORE THE SURGERY. PLATES AND SCREWS WERE UTILIZED IN COMBINATION WITH THE DRILLS DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20995124 ↗
• InjuryDec 20, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A PRIMARY SURGERY, TWO DRILL BITS BROKE WHILE DRILLING. THE INITIAL BREAKAGE LED TO THE USE OF A BACKUP DRILL, WHICH ALSO BROKE. DESPITE ATTEMPTS TO REMOVE THE BROKEN FRAGMENTS, THE DRILL BITS REMAINED UNRECOVERABLE AND WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED USING ANOTHER DRILL, WITH A DELAY OF TWO MINUTES. NO ISSUES WERE REPORTED WITH THE DRILLS THEMSELVES BEFORE THE SURGERY. PLATES AND SCREWS WERE UTILIZED IN COMBINATION WITH THE DRILLS DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20995123 ↗