NA 03.010.152Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982067999), received between Dec 1, 2020 and Jan 26, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS A PRE OPERATIVE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179970 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320909 ↗
• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE POST OP INSPECTION OF ITEMS WERE CANDY CANED, OR WARPED FROM OVER USAGE. MALLET HAD A ROUGH ETCHING AND BACKSLAP HAD THREADS WORN OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1)SD/HD SCRWDRVR SFT T25 3.5HEX/SF-RTN 280. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336846 ↗
• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON UNKNOWN DATE POST OP INSPECTION OF ITEMS WERE CANDY CANED, OR WARPED FROM OVER USAGE. MALLET HAD A ROUGH ETCHING AND BACKSLAP HAD THREADS WORN OUT. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. THIS REPORT IS FOR ONE (1SD/HD SCRWDRVR SFT T25 3.5HEX/SF-RTN 280. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336831 ↗
• MalfunctionDec 1, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE CUTTER FOR TITANIUM ELASTIC NAILS WAS BROKEN, TWO (2) 2.7MM REAMING ROD PUSHER 450MM LONG AND ONE (1) HELICAL BLADE/SCREW MEASURING DEVICE PIECE WERE BROKEN OFF. WHILE, THE STARDRIVE SCREWDRIVER SHAFT T25 3.5MM HEXAGONAL/SELF-RETAIN AND CANNULATED 3.5MM HEXAGONAL SCREWDRIVER SHAFT HEAD WERE STRIPPED. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. FRAGMENTS WERE GENERATED AND INSTRUMENTS WERE REMOVED. IT IS UNKNOWN IF PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928577 ↗