GLOBAL APG+ 2236-00-001Recalls & reported problems
Depuy (Ireland) · GLOBAL APG+ SIZER PIN GUIDE SIZE 40 +0mm · Class 1
All models of GLOBAL APG+ (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295105688), received between Jun 29, 2017 and Mar 31, 2026 — classified as 21 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 Incompatibility8
- Naturally Worn8
- Scratched Material4
- Material Twisted/Bent2
- Material Deformation1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information4
- No Consequences Or Impact To Patient4
- No Information2
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT DURING PRE-SURGERY SET-UP IT WAS OBSERVED THAT THE APG GLENOID SIZER 40MM +0 VERSION WAS BROKEN ON THE CONSIGNMENT TRAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24741891 ↗MalfunctionJul 7, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE GLENOID PIN GUIDE WOULD NOT STAY ON HANDLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22419780 ↗MalfunctionNov 1, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT ON (B)(6) 2024. THE 40 +0 PIN GUIDE WAS DAMAGED DURING NORMAL USE, AND THE PIN WON¿T GO THROUGH THE GUIDE.
Patient problems: Insufficient Information
MAUDE report 20586663 ↗MalfunctionJan 24, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
THE ITEMS ARE CRACKED. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18574427 ↗MalfunctionJan 10, 2024Naturally Worn; Naturally Worn
WEAR AND TEAR ON SIZER PIN GUIDES. 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 18484894 ↗MalfunctionNov 21, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT GUIDES HAVE GOUGES OUT OF THEM AND ARE NOT SMOOTH. 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 STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. (B)(4). DEVICE PROPERTY OF, NONE. DEVICE IN POSSESSION OF, NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST, TRUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18181862 ↗MalfunctionNov 16, 2023Break; Break
GLOBAL ICON AP TRAY ZNAUE0019 WAS SENT, HOSPITAL NOTICED BASE OF GUIDE PIN 223600001 WAS SNAPPED OFF. THIS OCCURRED ON CHECK IN AND ALLOWED TIME FOR A REPLACEMENT TRAY TO BE SENT. NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18147924 ↗MalfunctionNov 16, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE GLOBAL UNITE SIZER PIN GUIDES +0 ARE A WORN DOWN AND BEAT UP. THEY NEED TO BE REPLACED. THERE WERE DINGS AND SCRATCHES ON THE SIZERS. SURGICAL DELAY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18147319 ↗MalfunctionJul 21, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED: 1. THE TEETH ON THE SCREWDRIVER BROKE OFF AND WE USED ANOTHER ONE FROM A SECOND KIT. 2. THIS INSTRUMENT WAS SCRATCHED UP TOO BADLY TO BE RESTERILIZED. 3. THIS PRODUCT WAS SCRATCHED UP FROM YEARS OF USE AND NOT FIT FOR RESTERILIZATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17370184 ↗MalfunctionJul 20, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IN SURGERY ON FRIDAY (B)(6) 2023 THE SURGEON REPORTED THE PERIPHERAL DRILL BITS WERE BLUNT AND THE APG+ SIZER GUIDES WERE SLIGHTLY LOOSE ON THE HANDLE DUE TO WEAR. NO DELAY TO THE OPERATION AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS A HEAVILY USED KIT AND IS GENERAL WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17365213 ↗MalfunctionAug 23, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT SIZING DISC WON¿T STAY ON THE HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15277980 ↗MalfunctionJun 9, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE DEVICE HAS WORN DOWN AND WOULD NOT STAY 40+0 AND S2+0 APG PIN POSITIONERS WERE IN THE CURVED APG HANDLE. SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14648674 ↗MalfunctionJan 27, 2022Break; Break
SIZER PIN GUIDE SNAPPED IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13370974 ↗MalfunctionMar 23, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT DURING TOTAL SHOULDER IT WAS NOTED THAT THE 40 AND 44 SIZERS WERE NOT HOLDING ON THE GUIDE DUE TO WEAR. A SECOND SET WAS OPENED AND THESE WERE ALSO WORN. THIS CAUSED A 5-MINUTE DELAY TO SURGERY.
Patient problems: Insufficient Information
MAUDE report 11553545 ↗MalfunctionMar 23, 2021Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn; Device-Device Incompatibility; Material Twisted/Bent; Naturally Worn
IT WAS REPORTED THAT DURING TOTAL SHOULDER IT WAS NOTED THAT THE 40 AND 44 SIZERS WERE NOT HOLDING ON THE GUIDE DUE TO WEAR. A SECOND SET WAS OPENED AND THESE WERE ALSO WORN. THIS CAUSED A 5-MINUTE DELAY TO SURGERY.
Patient problems: Insufficient Information
MAUDE report 11553543 ↗MalfunctionOct 23, 2018Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE GUIDES IN THE SET NEED TO BE REPLACED BECAUSE THEY DO NOT LOCK ONTO THE HANDLE ANYMORE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7995591 ↗MalfunctionMar 20, 2018Break; Break
IT WAS REPORTED THAT THE APG + SIZER PIN GUIDE WAS FOUND BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7352377 ↗MalfunctionDec 29, 2017Break; Break
THE GLENOID SIZER PIN GUIDE (40+0) WAS BROKEN. IT HAS TWO TABS WHICH COMPRESS/EXPAND TO ATTACH A HANDLE AND ONE IS PARTIALLY BROKEN AWAY MEANING THE HANDLE CAN NO LONGER BE ATTACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7153954 ↗MalfunctionDec 3, 2017Break; Break
IT WAS REPORTED THAT THE GUIDE PIN BROKE DURING TRIAL, THE PEG SEPARATED FROM THE MAIN BODY. USED THE 44 PIN INSTEAD. THE OLD PIN WAS DISCARDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7078152 ↗MalfunctionOct 26, 2017Break; Break
IT WAS REPORTED THAT THE INSTRUMENT GUIDE BROKE DURING SET UP WHILE ASSEMBLING.
Patient problems: No Information
MAUDE report 6979039 ↗MalfunctionJun 29, 2017Break; Break
IT WAS REPORTED THAT THE SIZING DISKS WAS BROKEN.
Patient problems: No Information
MAUDE report 6678341 ↗
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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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