AOS Trocar Tip Guide Wire, 1.5mm x 150mm 0109-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848665000108), received between Feb 2, 2024 and Apr 18, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• MalfunctionApr 18, 2025Break; Break

  ON 03/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF A 0250-000 CALIBRATED DRILL BROKE DURING USE WHILE BEING USED IN A REGULAR FASHION. THEN, A 0109-150 1.5MM GUIDE PIN BROKE DURING USE WHILE TRYING TO BE REMOVED IN A REGULAR FASHION, AND THE BROKEN PIECE WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER REVISION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21866966 ↗
• InjuryFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT WHO UNDERWENT A PROCEDURE WHERE ARTHREX DEVICES WERE IMPLANTED WAS EXPERIENCING A PAINFUL REACTION. THE INITIAL PROCEDURE OCCURRED ON (B)(6) 2023. THE PATIENT BEGAN TO EXPERIENCE PAIN 3-4 WEEKS POST. THE PATIENT WAS REFERRED TO A PAIN SPECIALIST WHO SUGGESTED SHE WAS HAVING AN ALLERGIC REACTION AS THE SCAR WAS RED AND PUFFY. SHE NOTED SHE FEELS TERRIBLE PAIN AND THROBBING, AND WHEN ATTEMPTING TO LIFT, IT'S PAINFUL. THE SURGEON MENTIONED SHE COULD HAVE THE DEVICES REMOVED IN 6 MONTHS FROM HER SURGERY DATE. HOWEVER, SHE IS NOT SURE SHE CAN TAKE THE PAIN THAT MUCH LONGER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18634327 ↗
• InjuryFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT WHO UNDERWENT A PROCEDURE WHERE ARTHREX DEVICES WERE IMPLANTED WAS EXPERIENCING A PAINFUL REACTION. THE INITIAL PROCEDURE OCCURRED ON (B)(6) 2023. THE PATIENT BEGAN TO EXPERIENCE PAIN 3-4 WEEKS POST. THE PATIENT WAS REFERRED TO A PAIN SPECIALIST WHO SUGGESTED SHE WAS HAVING AN ALLERGIC REACTION AS THE SCAR WAS RED AND PUFFY. SHE NOTED SHE FEELS TERRIBLE PAIN AND THROBBING, AND WHEN ATTEMPTING TO LIFT, IT'S PAINFUL. THE SURGEON MENTIONED SHE COULD HAVE THE DEVICES REMOVED IN 6 MONTHS FROM HER SURGERY DATE. HOWEVER, SHE IS NOT SURE SHE CAN TAKE THE PAIN THAT MUCH LONGER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18632867 ↗
• InjuryFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT WHO UNDERWENT A PROCEDURE WHERE ARTHREX DEVICES WERE IMPLANTED WAS EXPERIENCING A PAINFUL REACTION. THE INITIAL PROCEDURE OCCURRED ON 10/03/2023. THE PATIENT BEGAN TO EXPERIENCE PAIN 3-4 WEEKS POST. THE PATIENT WAS REFERRED TO A PAIN SPECIALIST WHO SUGGESTED SHE WAS HAVING AN ALLERGIC REACTION AS THE SCAR WAS RED AND PUFFY. SHE NOTED SHE FEELS TERRIBLE PAIN AND THROBBING, AND WHEN ATTEMPTING TO LIFT, IT'S PAINFUL. THE SURGEON MENTIONED SHE COULD HAVE THE DEVICES REMOVED IN 6 MONTHS FROM HER SURGERY DATE. HOWEVER, SHE IS NOT SURE SHE CAN TAKE THE PAIN THAT MUCH LONGER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18632827 ↗
• InjuryFeb 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 01/19/2024, IT WAS REPORTED BY A PATIENT WHO UNDERWENT A PROCEDURE WHERE ARTHREX DEVICES WERE IMPLANTED WAS EXPERIENCING A PAINFUL REACTION. THE INITIAL PROCEDURE OCCURRED ON (B)(6) 2023. THE PATIENT BEGAN TO EXPERIENCE PAIN 3-4 WEEKS POST. THE PATIENT WAS REFERRED TO A PAIN SPECIALIST WHO SUGGESTED SHE WAS HAVING AN ALLERGIC REACTION AS THE SCAR WAS RED AND PUFFY. SHE NOTED SHE FEELS TERRIBLE PAIN AND THROBBING, AND WHEN ATTEMPTING TO LIFT, IT'S PAINFUL. THE SURGEON MENTIONED SHE COULD HAVE THE DEVICES REMOVED IN 6 MONTHS FROM HER SURGERY DATE. HOWEVER, SHE IS NOT SURE SHE CAN TAKE THE PAIN THAT MUCH LONGER. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18632799 ↗