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
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 ↗
Other TEMPLATE devices
- ATTUNE 2544-01-014Depuy (Ireland) · TEMPLATE802 reports
- ATTUNE 2545-00-546Depuy (Ireland) · TEMPLATE1 recall301 reports
- ARTICUL/EZE 2531-51-000Depuy (Ireland) · TEMPLATE323 reports
- DELTA XTEND 2307-95-000Depuy (Ireland) · TEMPLATE315 reports
- ATTUNE 2545-00-547Depuy (Ireland) · TEMPLATE1 recall231 reports
- ATTUNE 2544-00-520Depuy (Ireland) · TEMPLATE279 reports
- ATTUNE 2545-00-545Depuy (Ireland) · TEMPLATE1 recall221 reports
- ARTICUL/EZE 2530-91-000Depuy (Ireland) · TEMPLATE271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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