GLOBAL APG+ 2236-00-002Recalls & reported problems
Depuy (Ireland) · GLOBAL APG+ SIZER PIN GUIDE SIZE 44 +0mm · Class 1
All models of GLOBAL APG+ (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Global APG+ sizer pin guide is a reusable surgical sizing tool used during shoulder replacement to trial implant sizes. The 29 reports mostly describe the guide breaking, cracking, bending or wearing out with repeated use — including a trial tip snapping off during surgery — and none mention deaths or injuries. There are no recalls naming this device, and report numbers are flat over the past two 12-month periods.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10603295105695), received between Jun 29, 2017 and Nov 10, 2025 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Break” (14 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
- Break14
- Device-Device Incompatibility12
- Naturally Worn7
- Scratched Material4
- Crack3
- Material Twisted/Bent3
- Material Deformation2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient12
- Insufficient Information3
- No Information1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT DURING A LEFT SHOULDER REPAIR (TSR) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE TRIALING THE 44MM +0 SIZER PIN GUIDE FROM THE APG INSTRUMENT, THE SURGEON LEVERED ON THE TRIAL DURING INSERTION ONTO THE GLENOID AND THE CENTRAL PEG SNAPPED OFF. IT WAS REMOVED WITH NO ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23509982 ↗MalfunctionJan 6, 2025Break; Break
IT WAS REPORTED THAT THE TRIAL GLENOID SIZER BROKE INTO TWO PEICES WERE THE HANDLE ATTACHES. THERE WAS NO ADVERSE PATIENT CONSEQUENCES AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21082647 ↗MalfunctionJan 9, 2024Crack; Scratched Material; Crack; Scratched Material
CRACKED AND DAMAGED SIZER PIN GUIDE. 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 18475563 ↗MalfunctionDec 22, 2023Device-Device Incompatibility; Material Deformation; Naturally Worn; Scratched Material; Device-Device Incompatibility; Material Deformation; Naturally Worn; Scratched Material
ADDITIONAL INFORMATION RECEIVED. A. CAN YOU PLEASE CLARIFY, WHAT DO YOU MEAN BY ¿DAMAGED¿? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS THREADED OR ANY DEVICE INTERACTION. WORN AWAY. THE HEX COMPONENTS OF THE GUIDE HAVE BEEN BURRED OUT, SO THAT THEY NO LONGER FIT ONTO THE HEX COMPONENT OF THE GUIDE HANDLE. B. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. C. CAN YOU CONFIRM, THE EVENT DATE ONCE? UNSURE. GRADUAL WEARING OVER TIME, SO NO SPECIFIC DATE, ONLY INFORMED DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18387179 ↗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 18147322 ↗MalfunctionAug 15, 2023Break; Break
IT WAS REPORTED THAT THE SIZE 44MM 0 DEGREE GLENOID TRIAL TIP BROKE SNAPPED OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17550712 ↗MalfunctionAug 7, 2023Break; Break
DEVICE REPORT FROM DEPUY SYNTHES AUSTRALIA REPORTS AN EVENT AS FOLLOWS: DURING A LOAN KIT INSPECTION IT WAS DISCOVERED THAT THE MIDDLE OF SIZER GUIDE HAD BEEN DRILLED TO WIDEN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17469456 ↗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 17365195 ↗MalfunctionMar 15, 2023Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT THE PRODUCT IS DAMAGED, PIECES HAVE BROKEN OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16544248 ↗MalfunctionMar 8, 2023Break; Crack; Break; Crack
IT WAS REPORTED THAT THE SIZER GUIDE BROKE WHEN SCRUB NURSE WAS ASSEMBLING - PLASTIC WAS LIKELY ALREADY CRACKED OR BRITTLE. WERE ABLE TO UTILIZE A DIFFERENT SIZE GUIDE FOR PIN POSITIONING. 48+0 SIZER GUIDE WAS ALSO ALREADY DAMAGED WITHIN THE TRAY. MOST OF THE PLASTIC SIZER GUIDES APPEARED CLOUDY AND BRITTLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16501923 ↗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 15278056 ↗MalfunctionMar 14, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
THE INSTRUMENT IS WORN AND WILL NOT HOLD ONTO THE HANDLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13762251 ↗MalfunctionJan 31, 2022Break; Break
IT WAS REPORTED THAT THE APG+ MEASUREMENT TESTS 44 AND 48 WERE FOUND TO BE DAMAGED, ONE OF THEM EVEN BROKEN. IT CAUSED A SLIGHT DELAY IN SURGERY AND A CHANGE IN THE SURGICAL METHOD, BUT IT HAD NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13392021 ↗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 11553605 ↗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 11553529 ↗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 10951323 ↗MalfunctionJul 30, 2020Break; Break
STRATHFIELD PRIVATE HOSPITAL. THE PRODUCT FLAGGED AS BROKEN BY THE CUSTOMER. SET NUMBER: ZZINAUE0019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10347390 ↗MalfunctionJul 25, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 44 PIN SIZER GUIDE WILL NOT STAY ON HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10324189 ↗MalfunctionJul 25, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE 44 PIN SIZER GUIDE WILL NOT STAY ON HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10324188 ↗MalfunctionApr 6, 2020Break; Material Twisted/Bent; Naturally Worn; Scratched Material; Break; Material Twisted/Bent; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE DEFECTS WERE FOUND WHEN SETS RETURNED TO THE OFFICE FOR INSPECTION: SIZER PIN GUIDES CHIPS, DEEP SCRATCHES, OLD, WORN. SZ 1.5 MBT REV VIEW PLATE CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929510 ↗MalfunctionFeb 28, 2020Break; Crack; Break; Crack
DURING A SURGEON WORKSHOP/DEMONSTRATION THE GLENOID PIN GUIDE HAS BROKEN OFF WHILE ATTACHING BLACK HANDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9770771 ↗MalfunctionFeb 10, 2020Break; Break
IT WAS REPORTED THAT DURING PRIMARY TOTAL SHOULDER , APG DRILL GUIDE WAS BROKEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9689103 ↗MalfunctionDec 19, 2019Break; Break
IT WAS REPORTED THAT THE PIN GUIDE PLACEMENT OF A 44/+0 ANCHOR PEG GLENOID POST WAS BROKEN AND IT IS STILL INSERTED. THIS WAS AN INSTRUMENT ISSUE ONLY AND THE PIN WAS PLACED. THERE ARE 2 PIECES OF THE INSTRUMENT WERE RECOVERED AND NO DELAY TO THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9494882 ↗MalfunctionAug 15, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE GLENOID TRIALS WILL NO LONGER PROPERLY FIT ON HOLDER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8897003 ↗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 8734671 ↗
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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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