NA 1806-4265Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04546540196781), received between Aug 29, 2018 and May 1, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 3 DIFFERENT DRILLS BROKE DURING SURGERY. EVENT WAS SOLVED BY USING ANOTHER PRODUCT AVAILABLE (SAME REFERENCE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944288 ↗
• MalfunctionMay 1, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT 3 DIFFERENT DRILLS BROKE DURING SURGERY. EVENT WAS SOLVED BY USING ANOTHER PRODUCT AVAILABLE (SAME REFERENCE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943513 ↗
• MalfunctionJun 27, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL BROKEN OFF, NO FRAGMENT REMAINS TO THE PATIENT, THE PROCEDURE COMPLETED WITH NEW DRILL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830023 ↗
• MalfunctionJun 21, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "DRILL BREAKAGE WHEN DRILLING TO THE MOST DISTAL HOLE OF T2SCN WITH DIFFICULTY IN ADVANCING." ADDITIONALLY IT WAS REPORTED THAT THERE WAS DEBRIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14752240 ↗
• MalfunctionMar 26, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "BOTH DRILLS WERE BROKEN WHEN DRILLING FOR THE LATERAL STOP IN THE MOST PROXIMAL PART. DURING THE FIRST DRILLING, THE DRILL WAS CAREFULLY ADVANCED BECAUSE IT SOUNDED LIKE IT WAS INTERFERING WITH THE NAIL, BUT IT BROKE OFF IN THE MIDDLE STAGE. AFTER RE-TIGHTENING THE NAIL, THE SECOND DRILL WAS USED, BUT AGAIN THERE WAS AN INTERFERING SOUND, SO THE DRILL WAS PULLED OUT AND IN MORE CAREFULLY, BUT IT BROKE OFF IN THE MIDDLE STAGE AS WELL. THE MOST PROXIMAL HOLE WAS NOT USED BECAUSE TWO OTHER HOLES HAD ALREADY BEEN FIXED IN THE PROXIMAL PART BEFORE THAT. THE SURGEON SPECULATED THAT THE NAIL MAY HAVE BEEN BENT DUE TO THE USE OF AN 8-MM DIAMETER NAIL IN A CASE WITH A NARROW MEDULLARY CAVITY. PRECONNECTION CHECK WAS PERFORMED BEFORE INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13923304 ↗
• MalfunctionMar 25, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "BOTH DRILLS WERE BROKEN WHEN DRILLING FOR THE LATERAL STOP IN THE MOST PROXIMAL PART. DURING THE FIRST DRILLING, THE DRILL WAS CAREFULLY ADVANCED BECAUSE IT SOUNDED LIKE IT WAS INTERFERING WITH THE NAIL, BUT IT BROKE OFF IN THE MIDDLE STAGE. AFTER RE-TIGHTENING THE NAIL, THE SECOND DRILL WAS USED, BUT AGAIN THERE WAS AN INTERFERING SOUND, SO THE DRILL WAS PULLED OUT AND IN MORE CAREFULLY, BUT IT BROKE OFF IN THE MIDDLE STAGE AS WELL. THE MOST PROXIMAL HOLE WAS NOT USED BECAUSE TWO OTHER HOLES HAD ALREADY BEEN FIXED IN THE PROXIMAL PART BEFORE THAT. THE SURGEON SPECULATED THAT THE NAIL MAY HAVE BEEN BENT DUE TO THE USE OF AN 8-MM DIAMETER NAIL IN A CASE WITH A NARROW MEDULLARY CAVITY. PRECONNECTION CHECK WAS PERFORMED BEFORE INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13911282 ↗
• MalfunctionMar 15, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "T2SCN WAS INSERTED FOR A SUPRACONDYLAR FRACTURE AFTER TKA. THE SURGEON HEARD A STRANGE NOISE WHEN DRILLING THE SECOND HOLE, BUT PUSHED THE DRILL STRAIGHT IN AND THE TIP BROKE OFF. THE BROKEN TIP WAS LEFT IN THE BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 13768808 ↗
• MalfunctionJan 12, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED: "THE DRILL SHAFT BROKE WHEN IT WAS USED. THE BROKEN TIP WAS REMOVED FROM THE PATIENT DURING THE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236093 ↗
• MalfunctionJan 4, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN INSERTING A POLAR SCREW INTO THE SIDE OF THE NAIL, THE HAND OF THE SURGEON BECAME UNSTABLE AND THE DRILL WAS OVERLOADED, RESULTING IN BREAKAGE." UPDATE 12/17/2021: NO DEBRIS HAVE BEEN LEFT IN PATIENT¿S BODY. THE PROCEDURE COULD BE COMPLETED SUCCESSFULLY WITH A SUBSTITUTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13156037 ↗
• MalfunctionNov 10, 2021Fracture; Fracture

  THE PATIENT UNDERWENT SURGERY USING T2SCN FOR A SUPRACONDYLAR FRACTURE AFTER TKA. WHEN DRILLING WAS PERFORMED TO INSERT THE MOST DISTAL SCREW, THE DRILL CONTACTED THE NAIL OR PEG AND BROKE OFF AT ABOUT 4 CM FROM THE TIP. ADDITIONAL INFORMATION RECEIVED ON 10/29/2021: THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 30 MINS. THE TIP OF THE BROKEN DRILL REMAINED IN THE PATIENT'S BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12790816 ↗
• MalfunctionAug 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE DRILLING PROCESS, THE TIP OF THE DRILL WAS BROKEN AND ONLY THE TIP TEMPORARILY REMAINED TO THE PATIENT BONE. AFTER THAT, THE REMOVAL WAS SUCCESSFUL, BUT AN UNSCHEDULED SKIN INCISION WAS ADDED FOR THE REMOVAL, AND THE OPERATION TIME WAS EXTENDED BY ABOUT 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307296 ↗
• MalfunctionJun 15, 2021Break; Break

  IT WAS REPORTED T2SCN WAS USED FOR SUPRACONDYLAR FRACTURES AFTER TKA. WHEN THE SURGEON WAS DRILLING TO THE OBLIQUE HOLE, THE DRILL HIT THE FEMORAL COMPONENT AND BROKE. THE TIP OF THE DRILL BIT REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11999831 ↗
• MalfunctionFeb 25, 2021Fracture; Fracture

  AS REPORTED: "AT THE TIME OF INTRAMEDULLARY NAIL DRILLING (3RD SCREW FROM THE DISTAL SIDE OF T2SCN), THE TIP OF DRILL BROKE. THE SURGEON REMOVED IT FROM THE TIP OF THE DRILL AND INSERTED THE SCREW, BUT HE DID NOT INSERT IT BECAUSE IT INTERFERED WITH THE TKA IMPLANT (WHICH WAS PREVIOUSLY IMPLANTED) AND THE SCREW WAS UNABLE TO BE INSERTED. DR. CONSIDERED THAT TIP OF THE DRILL BROKE BECAUSE IT SLIGHTLY INTERFERED WITH THE TKA IMPLANT IN THE SUPRACONDYLAR FRACTURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382622 ↗
• MalfunctionJan 13, 2021Fracture; Fracture

  AS REPORTED: "THE PATIENT UNDERWENT THE INITIAL OPERATION FOR FEMORAL CONDYLE. DURING THE OPERATION, THE DRILL BROKE WHEN DRILLING AT THE PROXIMAL TARGET DEVICE. SUCCESSFUL RESCUE, NO DRILL LEFT IN THE BODY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168006 ↗
• MalfunctionDec 16, 2020Fracture; Fracture

  AS REPORTED: "T2 ANKLE NAIL SURGERY. WHEN DRILLING TO THE MOST DISTAL PART OF THE NAIL, THE DRILL ADVANCED OUTSIDE THE NAIL (INTRABONE). AT THAT TIME, THE TIP OF THE DRILL (1806-4265) BROKE ABOUT 3 CM. THE BROKEN DRILL WAS REMOVED WITH FORCEPS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11016069 ↗
• MalfunctionAug 7, 2020Fracture; Fracture

  AS REPORTED: "DURING THE OPERATION, THE DRILL BIT HIT TO THE TKA AND BROKE. THE BROKEN TIP OF THE DRILL BIT WAS LEFT IN THE PATIENT BODY. THE OPERATION COMPLETED WITHOUT PROBLEM. THERE WAS NO HEATH IMPACT TO THE PATIENT".

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10379522 ↗
• MalfunctionApr 15, 2020Fracture; Fracture

  AS REPORTED: "WHILE DRILLING IN ORDER TO INSERT OBLIQUE SCREW, A DRILL INTERFERED WITH NAIL. DRILL GOT BROKEN AND THE TIP REMAINED IN BONE. THE TIP WAS REMOVED. SCREW WAS INSERTED TO ANOTHER SITE AND PROCEDURE WAS COMPLETED."

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9966002 ↗
• MalfunctionMar 16, 2020Fracture; Fracture

  AS REPORTED, DURING ORIF PROCEDURE WHEN A LOCKING SCREW WAS ATTEMPTED TO INSERT, THE DRILL OF T2ANKLE NAIL WAS BROKEN IN THE CALCANEUS. AS IT WAS UNABLE TO TAKE OUT, THE BROKEN PIECE WAS LEFT INSIDE THE BODY. THE REPORTING SURGEON¿S OPINION: THE PATIENT¿S BONE WAS TOO HARD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9837387 ↗
• MalfunctionSep 16, 2019Break

  AS REPORTED: "DURING T2 FEMORAL SURGERY, THE DRILLS BROKE WHEN THEY WERE USED TO DRILL FOR THE STATIC SCREW HOLE OF THE NAIL. THE PROCEDURE WAS PROGRESSED WITHOUT PROBLEM AFTER THAT." NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9073059 ↗
• MalfunctionSep 16, 2019Break

  AS REPORTED: "DURING T2 FEMORAL SURGERY, THE DRILLS BROKE WHEN THEY WERE USED TO DRILL FOR THE STATIC SCREW HOLE OF THE NAIL. THE PROCEDURE WAS PROGRESSED WITHOUT PROBLEM AFTER THAT." NO ADVERSE CONSEQUENCES OR SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9073054 ↗
• MalfunctionJan 17, 2019Break; Malposition of Device

  IT WAS BROKEN THE DRILL DURING DRILLING WAS IT WAS WITHOUT NOTICING THAT THE SLEEVE WAS DISPLACED BY THE SOFT TISSUE DURING SURGERY AND THE DRILL DID NOT THROUGH THE NAIL. FOR THAT REASON, THE SURGEON PULLED OUR A BROKEN DRILL TIP FORM THE OPPOSITE SIDE WHERE THE DRILL TIP WAS REMOVED. THE SURGEON THINKS THAT THE SLEEVE WAS PUSHED BY THE SOFTY TISSUE AND BELIEVE IT IS NOT A MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257051 ↗
• MalfunctionOct 30, 2018Break

  DURING T2 SURGERY, THE DRILL WAS BROKEN OFF WHEN DRILLING WITH POWER TOOL. THE BROKEN DRILL WAS COMPLETELY REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER DRILL. IN THE SURGEON'S OPINION, THE INSTALLATION OF THE DRILL TO THE POWER TOOL WAS INAPPROPRIATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8021008 ↗
• MalfunctionAug 29, 2018Break; Noise, Audible

  WHEN THE SURGEON TRIED TO RE-DRILL A PROXIMAL OBLIQUE HOLE OF T2GTN WHICH WAS ONCE DRILLED, THE DRILL BROKE OFF INSIDE THE PATIENT'S BONE WITH NOISE LIKE THE DRILL AND THE NAIL INTERFERING. THE BROKEN DRILL WAS COMPLETELY REMOVED FROM THE PATIENT. THE SURGERY WAS CONTINUED WITH ANOTHER SAME ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7827320 ↗