NA 03.221.251Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982277022), received between Jun 5, 2023 and Mar 17, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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.

• MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON'T CONNECT ON QC. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620879 ↗
• MalfunctionMar 17, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE STRIPPED, WON¿T CONNECT ON QC. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620862 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHERE A RFNA WAS INSERTED, WAS MALLETING IN WITH SLEEVE IN JIG. SLEEVES WERE NOT ABLE TO BE DRILLED THROUGH BECAUSE IT HIT NAIL AND THEY WERE STUCK. UNABLE TO TAKEN OUT - MALLET ALSO WAS CHIPPED IN PROCESS. NAIL WAS NOT BILLED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)BENDING DRIVER F/ 3.5MM VA LOCKING HOLES. THIS IS REPORT 5 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060338 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHERE A RFNA WAS INSERTED, WAS MALLETING IN WITH SLEEVE IN JIG. SLEEVES WERE NOT ABLE TO BE DRILLED THROUGH BECAUSE IT HIT NAIL AND THEY WERE STUCK. UNABLE TO TAKEN OUT - MALLET ALSO WAS CHIPPED IN PROCESS. NAIL WAS NOT BILLED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)BENDING DRIVER F/ 3.5MM VA LOCKING HOLES. THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059751 ↗