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GLOBAL STEPTECH APG 2230-00-009Recalls & reported problems

Depuy Orthopaedics, Inc. · GLOBAL STEPTECH APG SIZER PIN GUIDE SIZE 48 +3mm · Class 1

All models of GLOBAL STEPTECH APG (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
12
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295102823), received between Aug 13, 2018 and Jan 27, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break8
  • Device-Device Incompatibility3
  • Crack2

Patient problems

  • No Clinical Signs, Symptoms or Conditions9
  • No Consequences Or Impact To Patient3

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 27, 2026Device-Device Incompatibility

    IT WAS REPORTED THAT 48 +3 AND 56 +3 APG DRILL GUIDE WILL NOT HOLD IN HANDLE. NO DELAY TO SURGERY OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24193472 ↗
  • MalfunctionFeb 7, 2024Break; Break

    THIS INSTRUMENT IS COMPOSED OF 1 PART. THE INSTRUMENT CONTAINS A BROKEN TIP. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18659696 ↗
  • MalfunctionAug 16, 2023Crack; Crack

    IT WAS REPORTED THAT DEVICE IS DAMAGED, VERY BRITTLE AND CLOSE TO CRACKING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17555559 ↗
  • MalfunctionJul 27, 2023Break; Break

    ADDITIONAL INFORMATION RECEIVED STATES THAT ALL BROKEN PIECES WERE FOUND AND DISCARDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17406884 ↗
  • MalfunctionJun 6, 2023Break; Crack; Break; Crack

    IT WAS REPORTED THAT GLENOID SIZER GUIDES FROM TRAY WERE CRACKED AND DAMAGED DURING CASE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17073068 ↗
  • MalfunctionMay 10, 2023Break; Break

    IT WAS REPORTED THAT THE POST ON THE 48 +3 SIZER HAS BROKEN OFF THE BACK OF THE PIN GUIDE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16905150 ↗
  • MalfunctionMay 23, 2022Break; Break

    IT WAS REPORTED THAT AFTER PINING THE 48MM + 3 GLENOID SIZER GUIDE THE SURGEON WAS REMOVING THE GUIDE OFF THE GUIDE PIN AND THE SIZER GUIDE BROKE INTO TWO PIECES. ALL PIECES WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT AND THE SURGERY SUCCESSFULLY PROCEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14472476 ↗
  • MalfunctionFeb 23, 2022Break; Break

    BROACH STICKS TO BROACH HANDLE. GUIDE IS BROKEN. ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13586543 ↗
  • MalfunctionDec 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

    SURGEON ASKED THAT WE REPLACE SOME OF THE SIZING/PIN GUIDES FOR THE ANCHOR PEG PLUS INSTRUMENTS. THE DISKS ARE "SLIPPING" ON THE HANDLE. NO PATIENT CONSEQUENCES OR SURGICAL DELAYS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10951406 ↗
  • 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 8734670 ↗
  • MalfunctionOct 9, 2018Break; Break

    IT WAS REPORTED THAT THE PIN SIZER GUIDE WAS BROKEN.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7949214 ↗
  • MalfunctionAug 13, 2018Break; Break

    IT WAS REPORTED THAT THE SIZER WAS STUCK IN THE HANDLE AND BROKE WHEN TRYING TO REMOVE IT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7776298 ↗

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Sources and updates

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