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GLOBAL STEPTECH APG 2230-00-015Recalls & reported problems

Depuy Orthopaedics, Inc. · GLOBAL STEPTECH APG SIZER PIN GUIDE SIZE 56 +3mm · Class 1

All models of GLOBAL STEPTECH APG (12)

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

Adverse event reports
8
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295102885), received between Sep 22, 2017 and Jan 27, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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: 0 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: 1 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

  • Break3
  • Device-Device Incompatibility3
  • Appropriate Device Problem Term/Code Not Available1
  • Crack1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Consequences Or Impact To Patient3
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 8 most recent of 8 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 24193600 ↗
  • MalfunctionJan 21, 2025Crack; Crack

    IT WAS REPORTED THAT THE INSTRUMENT WAS CRACKED. THE PRODUCT DAMAGE DOCUMENTED 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 ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21199580 ↗
  • 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 10951366 ↗
  • MalfunctionMar 19, 2020Break; Break

    AFTER DRILLING THE CENTRAL PIN THROUGH THE DRILL GUIDE IN QUESTION, THE DRILL GUIDE BROKE AS THE SURGEON REMOVED IT FROM THE JOINT SPACE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9856922 ↗
  • 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 8734662 ↗
  • MalfunctionNov 26, 2018Break; Break

    GUIDE 56 +3 BROKE WERE YOU CONNECT THE HANDLE. PROLONGED SURGERY: 15 MIN.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8101311 ↗
  • MalfunctionJul 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT CLEAR SIZERS DO NOT LOCK ONTO HANDLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7670119 ↗
  • InjurySep 22, 2017Break; Break

    IT WAS REPORTED THAT UPON REMOVAL THE +3 GLENOID SIZER PIN GUIDE POST BROKE OFF IN THE HANDLE.

    Patient problems: No Information

    MAUDE report 6886893 ↗

Other TEMPLATE devices

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Sources and updates

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