GLOBAL STEPTECH APG 2230-00-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295102830), received between Nov 16, 2017 and Sep 1, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2021Break; Break

  IT WAS REPORTED THAT PRIOR TO SURGERY START, WHEN THE SCRUB NURSE LOADED THE 48 +5 PIN GUIDE ONTO THE HANDLE, THE PLASTIC TAB BROKE OFF. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410770 ↗
• MalfunctionJun 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTACHMENT PEG WAS SO WORN DOWN FROM BEING USED, IT WOULD NOT STAY ATTACHED TO THE HANDLE. EVERY TIME THE DOCTOR PUT IT IN THE SHOULDER, IT FELL OFF THE HANDLES. NO PARTS BROKE IN PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734681 ↗
• MalfunctionNov 16, 2017Break; Break

  IT WAS REPORTED THAT DUE TO CONFINED SPACE, THE PIN GUIDE BROKE AS IT WAS BEING REMOVED.

  Patient problems: No Information

  MAUDE report 7036431 ↗