NA 03.037.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982070258), received between Oct 11, 2019 and Feb 12, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF AN AWL IS STARTING TO SHEAR OFF AND NEEDS TO BE REPLACED. NO PATIENT HARM OR DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364277 ↗
• InjuryOct 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2024 , A BOX OF THE BASIC INSTRUMENTS OF THE TN ADVANCED WERE NOT SENT. THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20439778 ↗
• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE T-HANDLES WERE SPINNING AND BENT. IT WAS ALSO NOTED THAT THE AWL WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 8MM CANNULATED CURVED AWL.THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032600 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT ON JUN 10, 2024 THE TIP OF THE INSTRUMENT WAS DAMAGED/CHIPPED. THERE WAS NO INVOLVEMENT OF ANY OPERATION OR ANY PATIENT. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 8MM CANNULATED CURVED AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684378 ↗
• MalfunctionMar 13, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DEVICES WERE BROKEN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 8MM CANNULATED CURVED AWL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529078 ↗
• MalfunctionOct 11, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE WHILE PUTTING THE SETS BACK TOGETHER AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE MONOBLOC FLEXIBLE REAMER AND MEDULLARY REAMER HEAD HAVE APPEARED TO BE DULL DURING AN INSPECTION. AN AWL WAS ALSO NOTICED TO HAVE AN ISSUE WHERE THE RUBBER ON THE HANDLE OF THE AWL WAS DAMAGED AND COMING OFF. ALL THE REPORTED DEVICES WERE NO LONGER USABLE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 8MM CANNULATED CURVED AWL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9178947 ↗