NA 03.820.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034731360), received between Feb 1, 2019 and Sep 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (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 16, 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.

• MalfunctionSep 10, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715131 ↗
• MalfunctionMar 6, 2024Failure to Cut; Material Twisted/Bent; Scratched Material; Failure to Cut; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING PRE-SURGICAL CHECK, IT WAS FOUND THAT THE TIP OF THE AWL IN QUESTION WAS NOT SHARP. THE AWL WAS BENT AND NICKED. THERE WAS NO PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN AWL 12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845762 ↗
• MalfunctionNov 27, 2023Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING SURGERY AN AWL WAS DISCOVERED TO HAVE A BENT TIP. AWL HAD GONE THROUGH THE SOFT PLASTIC TIP AND THE END WAS BENT. THEY DIDN'T KNOW IF THIS WAS DAMAGED DURING SHIPPING OR IF IT HAD BEEN RETURNED FROM THE FIELD WITH A BENT TIP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) AWL 12MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18212662 ↗
• MalfunctionAug 3, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE AWL WAS DULL AND DIFFICULT TO USE. THE AWL WAS ABLE TO BE USED FOR SURGERY ANYWAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR AN AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12269091 ↗
• MalfunctionMay 7, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SURGEON WAS USING THE AWL AND NOTED THAT IT WAS BLUNT. THE SURGEON WAS ABLE TO CONTINUE TO USE THE AWL, HOWEVER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A AWL 12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790624 ↗
• MalfunctionFeb 1, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE AWL BROKE AND HAS A BENT TIP DURING A PRODISC-C PROCEDURE. IT IS UNKNOWN IF THE TIP WAS BENT PRIOR TO PROCEDURE OR WHILE IT WAS BEING USED. THE SURGEON DID NOT HAVE ANY ISSUES WHILE USING THE DEVICE. NO FRAGMENTS WERE GENERATED FROM BROKEN DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) AWL 12MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298841 ↗