NA 1806-3550Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04546540196644), received between Nov 22, 2022 and Jul 27, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50002759 ↗
• InjuryMay 20, 2026Fracture

  IT WAS REPORTED THAT A DRILL BIT BROKE DURING DRILLING AND FRAGMENTS REMAIN INSIDE THE PATIENTS BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25236734 ↗
• InjuryJun 23, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL BIT BROKE AND WAS LEFT INSIDE THE PATIENT'S HUMERUS, AND THE SURGERY WAS COMPLETED."

  Patient problems: Foreign Body In Patient

  MAUDE report 22310695 ↗
• InjuryDec 20, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING HUMERAL NAILING, WHILE PASSING THROUGH THE OBLONG HOLE OF THE NAIL, THE TIP OF THE DRILL BIT BROKE OFF AND BECAME STUCK IN THE PATIENT'S BONE, THE PIECE OF DRILL BIT WAS LEFT IN PLACE, REMOVAL WOULD HAVE BEEN TOO DISFIGURING. THERE WAS NO OTHER CONSEQUENCES, THE INCIDENT WAS ISOLATED. THE OPERATION WAS DELAYED BY AROUND 20 MINUTES." 2/17/2024: ADDITIONAL INFORMATION RECEIVED: NO OTHER EQUIPMENT WAS USED TO DRILL THE BONE APART FROM A SKIN INCISION AND DISSECTION TO THE DISTAL HUMERAL BONE POSTERIORLY. THE DRILL SCRATCHED THE DISTAL NAIL HOLE (AS USUAL), A TRAJECTORY CORRECTION WAS IMMEDIATELY UNDERTAKEN, BUT THE BREAKING SOUND HAD ALREADY OCCURRED. IT WAS THEN IMPOSSIBLE TO DRILL THE 2ND CORTEX. ON REMOVING THE DRILL, THE DISTAL BREAK WAS DISCOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20993628 ↗
• MalfunctionOct 23, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "DURING SURGERY, THE TIP OF THE DRILL BIT BROKE OFF IN THE DISTAL LOCKING HOLE OF THE T2 HUMERAL NAIL. IT IS UNKNOWN WHETHER THE DRILL BIT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT'S BODY."

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20515765 ↗
• InjuryAug 23, 2024Break; Fracture; Break; Fracture

  AS REPORTED : ''DURING SURGERY DRILL BIT BROKE AND REMAINED INSIDE THE PATIENT, THE SURGEON TRIED TO REMOVE IT AND COULD NOT, SO HE DECIDES TO LEAVE IT IN SITU. THE PATIENT NEEDS TO BE MONITORED BECAUSE PART OF THE DRILLS REMAINS INSIDE.''

  Patient problems: Foreign Body In Patient

  MAUDE report 20046993 ↗
• InjuryAug 15, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED: NAIL IMPLANTATION FOR FRACTURE BY ARM WRESTLING WAS PERFORMED. THE PATIENT'S BONE QUALITY WAS HARD. A RADIOLUCENT DRILL WAS USED TO DRILL THE DISTAL SIDE. HOWEVER, IT WAS DIFFICULT TO DRILL THE BONE. SINCE THERE WAS A HOLE IN THE ANTERIOR CORTEX, THE SURGEON TO USED THE STRAIGHT DRILL, WHICH IS EASIER TO DRILL. HOWEVER, THE TIP OF THE STRAIGHT DRILL WAS BROKEN DURING DRILLING. THE DRILL BIT HAD BROKEN AS IT HAD FIT SNUGLY INTO THE NAIL HOLE, SO THE SURGEON DETERMINED IT WOULD BE DIFFICULT TO REMOVE. THUS, THE SURGERY WAS COMPLETED WHILE THE BROKEN DRILL BIT WAS LEFT IN THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19992621 ↗
• MalfunctionSep 19, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL DAMAGED IN SURGERY. ACCORDING TO INFORMATION ON THE NOTIFICATION FORM, ALL FRAGMENTS WERE RECOVERED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777821 ↗
• MalfunctionMar 22, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "THE DRILL BIT BROKE IN THE NAIL DURING DISTAL LOCKING. THE PIECE REMAINED IN THE NAIL AND ANOTHER SCREW WAS PLACED IN ANOTHER LOCATION."

  Patient problems: Foreign Body In Patient

  MAUDE report 16591965 ↗
• MalfunctionNov 22, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT: "ON (B)(6) 2022, THE TRAUMA UNIT DECLARED AN INCIDENT INVOLVING A DRILL BIT DURING AN OSTEOSYNTHESIS OPERATION BY LONG CENTROMEDULLARY NAILING. THE PATIENT WAS HOSPITALIZED FOR A TRANSVERSE FRACTURE OF THE MIDDLE 1/3 OF THE LEFT HUMERAL DIAPHYSIS. WHEN MAKING THE DRILL BIT TO PUT THE NAIL FIXING SCREW, THE DRILL BIT BROKE AND REMAINED IN THE NAIL. THIS RESULTED IN NOT BEING ABLE TO PLACE FIXATION SCREWS AT THE PROXIMAL LEVEL. ON THE OTHER HAND, THE FIXATION SCREW COULD BE PLACED AT THE DISTAL LEVEL." THERE WAS A 10 MINUTE SURGICAL DELAY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15842480 ↗