NA 03.010.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982067135), received between Jun 30, 2020 and Jul 11, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT TIP WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT AND NO OPERATION WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487292 ↗
• MalfunctionAug 31, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, PORTION OF AWL RETAINED IN PATIENT. THERE WAS NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 12.0MM CANNULATED AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15327772 ↗
• MalfunctionOct 1, 2021Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE POINT OF THE DEVICE WAS BENT AND BLUNT. THIS REPORT IS FOR ONE (1) 12.0MM CANNULATED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562592 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE TIBIAL NAIL CANNULATED AWL TIP WAS BROKEN OFF. THE TIBIAL NAIL INSTRUMENTS WERE GOING THROUGH THE DECONTAMINATION WASH AND THE CANNULATED AWL WAS LODGED INTO THE WINDOW OF THE WASHER. THE DOOR OPENED AND CAUGHT THE TIP OF THE CANNULATED AWL WHICH REMOVED THE TIP. THIS HAPPENED IN THE WASHER AFTER THE CASE. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 12.0MM CANNULATED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214448 ↗