NA 2351-4218SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327350319), received between Jul 22, 2019 and Mar 25, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Fracture

  AS REPORTED BY THE CUSTOMER: "PATIENT OPERATED ON FOR LEFT TIBIA FRACTURE. SINGLE-USE DISTAL LOCKING DRILL BROKE INSIDE THE PATIENT. IMPOSSIBLE TO RETRIEVE THE PIECE."

  Patient problems: Foreign Body In Patient

  MAUDE report 24692114 ↗
• InjuryAug 21, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED: "4.2X185MM DRILL BIT BROKE OFF IN OUR T2 ALPHA RETROGRADE NAIL THE DRILL BIT HIT THE NAIL. WE DID NOT HAVE PERFECT CIRCLES WHEN THE SURGEON TRIED TO DRILL THROUGH THE HOLE. A 12X340 RETROGRADE NAIL WAS USED. A 4.2X130 DRILL WAS OPENED AFTER THE 185 BROKE. A 5X40MM SCREW WAS INSERTED IN THE HOLE ABOVE THE ONE WITH THE BROKE DRILL BIT IN IT. THE BROKEN DRILL BIT (ONE PIECE) IS STILL IN THE HOLE OF THE NAIL. IT IS IN THE CANAL OF THE FEMUR AND NOT STICKING OUT OF EITHER CORTEX. IT COULD NOT BE RETRIEVED INTRAOPERATIVELY".

  Patient problems: Foreign Body In Patient

  MAUDE report 22862507 ↗
• InjuryJun 6, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "SURGICAL DRILL BIT TIP BROKE DURING SURGERY (RIGHT FEMUR). OR TEAM WAS UNABLE TO RECOVER THE DRILL BIT TIP".

  Patient problems: Foreign Body In Patient

  MAUDE report 22158709 ↗
• MalfunctionMay 12, 2025Break; Entrapment of Device

  SURGICAL DRILL BIT TIP BROKE DURING SURGERY (RIGHT FEMUR). OPERATING ROOM TEAM WAS UNABLE TO RECOVER THE DRILL BIT TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 22001947 ↗
• InjuryMar 22, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A SINGLE USE DRILL BIT SNAPPED DURING A CASE. THE DRILL SNAPPED MOST LIKELY NOT BEING FULLY STRAIGHT THROUGH THE LOCKING HOLE. IT WAS THE PROXIMAL HOLE IN A RETROGRADE NAIL IN QUITE A LARGE LEG SO CAN BE MORE TRICKY THAN THE DISTAL LOCKING IN A ANTEGRADE NAIL. IT WAS THROUGH TO THE NEAR CORTEXT AND THE NAIL BUT JUST SNAPPED WHEN I WAS TRYING TO GO THROUGH THE FAR CORTEX. IT WAS COMPLETELY FLUSH IN THE BONE AND NO WAY ITS GOING TO COME OUT OR CAUSE ANY ISSUE. UPDATE 01/MAR/24: WE USED ANOTHER DRILL (SHORT ONE) AND ALL FINE NO CONCERNS PROBLEM WAS NOT 100% AT 90 DEGREES TO THE HOLE AND IT SNAPPED THE DRILL. THE PATIENT WAS VERY LARGE AT THE THIGH AND NEEDED TO THE LONG DRILL TO GET TO BONE. SECOND LOCKER DOWN WITH SHORT DRILL NO PROBLEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 18960541 ↗
• MalfunctionJan 23, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS IMPLANTING AN ANTEGRADE FEMORAL NAIL. ONCE THE NAIL WAS PLACED, TWO PROXIMAL SCREWS WERE PLACED IN THE NAIL. AS THE SURGEON DRILLED FOR THE DISTAL LOCKING SCREW THE DRILL BIT WENT IN AT A SLIGHT ANGLE, AT THAT TIME THE DRILL BIT TORQUED AGAINST THE NAIL AND THE TIP OF THE DRILL BROKE OFF. NOT WANTING TO CAUSE ANYMORE TRAUMA TO THE PATIENT, THE SURGEON LEFT THE TIP OF THE DRILL BIT AND PROCEEDED TO LOCK THE OTHER DISTAL HOLES.

  Patient problems: Foreign Body In Patient

  MAUDE report 16223526 ↗
• MalfunctionJul 22, 2019Break

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A LEFT FEMUR, THE 180 DRILL BROKE GOING THROUGH THE DISTAL HOLE OF THE ALPHA GT NAIL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8814456 ↗