INSTRUMENT 6541-4-518Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327241440), received between Jan 5, 2017 and Nov 5, 2024 — classified as 1 injury, 9 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 18, 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.

• MalfunctionNov 5, 2024Fracture; Fracture

  DURING THE SURGERY, THE SURGEON USED THE DRILL, AND WHILE PERFORATING THE MEASUREMENT GUIDE, IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609623 ↗
• MalfunctionOct 1, 2024Fracture; Fracture

  BREAKAGE WHEN USING DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342921 ↗
• MalfunctionJul 30, 2024Fracture; Fracture

  ''DRILL BROKE OFF WHILE PRE-DRILLING A PIN HOLE. THE PROCEDURE WAS COMPLETED USING REPLACEMENT. ALL BROKEN PARTS HAVE BEEN COMPLETELY REMOVED, FOR DATA PROTECTION REASONS, NO INFORMATION OF THE PATIENT IS POSSIBLE.''.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861440 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  1/8¿ DRILL SNAPPED INTRAOP AS IT WAS BEING REMOVED FROM PATIENT. SNAPPED PORTION REMOVED AND OPERATION CONTINUED. DRILLING WAS COMPLETE SO NO NEED TO ORGANISE REPLACEMENT. NOTICED BY SURGEON INTRAOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643242 ↗
• MalfunctionJun 29, 2024Fracture; Fracture

  ONE EIGHTH PEG DRILL BROKE DURING DRILLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19640543 ↗
• InjuryMar 11, 2024Fracture; Fracture

  DURING DRILLING OF TRIATHLON AP SIZER, THE DRILL BROKE OFF AND STRAYED INTO THE BONE, WHICH WAS RADIOGRAPHED AND REMOVED. IN ADDITION, BONE GRAFTING WAS PERFORMED BECAUSE OF REMOVAL BONE TO LOCATE THE BROKEN DRILL.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873006 ↗
• MalfunctionDec 26, 2018Fracture; Fracture

  TRIATHLON1 1/8TH DRILL BIT SNAPPED WHILE PRE DRILLING HOLE FOR TIBIAL HEADED PIN. SEEN BY SURGEON AND REP DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8198075 ↗
• MalfunctionDec 17, 2018Break; Material Fragmentation

  SURGEON WAS USING A DRILL DURING THIS PROCEDURE AND THE DRILL BIT BROKE WHILE IN USE. ALL PIECES OF DRILL BIT WERE FOUND AND REMOVED FROM PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8168756 ↗
• MalfunctionNov 12, 2018Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT 1/8" PEG DRILL BELONGING TO PTG TRIATHLON IS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061871 ↗
• MalfunctionJan 5, 2017Break; Insufficient Device Problem Information; Insufficient Device Problem Information

  WHILE PRE-DRILLING TIBIAL BASEPLATE, 1/8 DRILL WITH THE STOP BROKE. LOOSE PIECE WAS FOUND. NO ADVERSE CONSEQUENCES.

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

  MAUDE report 6226790 ↗