GLOBAL APG+ 2236-00-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10603295105701), received between Jun 29, 2017 and Jun 30, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Break” (29 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 48MM + 0 SIZING GUIDE ON THEIR APG+ TRAY WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25664154 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT THE SURGICAL TECHNICIAN SNAPPED POST OFF OF 48 +0 PIN GUIDE WHEN TRYING TO REMOVE FROM HANDLE. NO DELAY TO SURGERY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176088 ↗
• MalfunctionApr 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE TRIAL WAS WORN DOWN AND THE HANDLE WOULD NOT HOLD THE TRIAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851966 ↗
• MalfunctionJan 22, 2026Crack

  IT WAS REPORTED DURING PROCESSING OF THE INSTRUMENT, STERILE PROCESSING FOUND THE PLASTIC GUIDE WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146263 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE SIZER PIN GUIDE HAS SNAPPED OFF. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004115 ↗
• MalfunctionJan 29, 2025Break; Break

  THE PRODUCT DAMAGE OF BROKEN 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 PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266423 ↗
• MalfunctionJan 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SIZER PIN GUIDE 48 0 IS WORN. THERE WAS NO DELAY AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178696 ↗
• MalfunctionJul 23, 2024Break; Break

  THIS INSTRUMENT IS COMPOSED OF 1 PART. IT WAS REPORTED THAT THE INSTRUMENT IS CHIPPED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807912 ↗
• 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 18574332 ↗
• 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 18484915 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED THAT THE SIZER PIN GUIDE HAS A CHIPPED POST. 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 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 18236600 ↗
• MalfunctionNov 28, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP: I DID NOT VISUALLY INSPECT THE TRAY, I WAS INFORMED AT THE CASE ON 23/11 - THANKFULLY WE DID NOT REQUIRE THE INSTRUMENTS AS WE USED A REVERSE SHOULDER INSTEAD. I WAS TOLD BY THE LOANS TEAM THAT THE SIZER DISC LISTED HAD BROKEN INTO TWO PIECES, ONE WAS STUCK INSIDE THE INSERTION HANDLE AND THE OTHER WAS THE MAIN BODY. HE WAS ABLE TO REMOVE THE BROKEN PIECE FROM THE INSERTION HANDLE PRIOR TO STERILIZATION SO THAT IT COULD STILL BE USED, BUT THE MAIN BODY OF THE SIZER DISC WAS LEFT ON THE TRAY SO THAT IT COULD BE REPORTED AND REPLACED. THE SIZER GUIDES ARE PLASTIC, SO THE ITEM SNAPPED. I HAVE SEEN THIS HAPPEN BEFORE WITH THESE PARTICULAR ITEMS FROM THIS SET AND HAVE ATTACHED AN IMAGE BELOW TO SHOW AS AN EXAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221249 ↗
• MalfunctionNov 16, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  ALL TRIALS AND SIZER 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148227 ↗
• 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 18147323 ↗
• MalfunctionNov 3, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE SIZER PIN GUIDE 48+0 BROKE DUE TO WEAR AND TEAR AND MULTIPLE STERILIZATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065471 ↗
• 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 48- SIZER GUIDE HAD BROKEN OFF. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469576 ↗
• MalfunctionJun 8, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE HEX CONNECTION OF THE APG+ WIRE PLACEMENT GUIDE BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 17093211 ↗
• MalfunctionMay 10, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT PEG THAT ATTACHES TO THE HANDLE BROKE OFF INSIDE THE BLACK INSERTER HANDLE. THIS WAS AFTER THE CASE AND NO ISSUES OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903885 ↗
• 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 16544245 ↗
• 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 16501922 ↗
• MalfunctionJan 13, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE APG+ SIZER PIN GUIDE 48+0 BROKE AWAY FROM THE PIECE CONNECTING IT TO THE CANNULATED CURVED HANDLE, LEAVING THE BROKEN PLASTIC PIECE LEFT STUCK IN THE DISTAL END OF THE CURVED HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159311 ↗
• MalfunctionDec 2, 2022Break; Break

  IT WAS REPORTED THAT SIZE 48 0 DEGREE YELLOW SIZING SHIM FOR APG+ SNAPPED WHEN TRYING TO PULL OFF HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906504 ↗
• MalfunctionNov 16, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE GLOBAL APG+ 48 +0 CLEAR SIZER NO LONGER ABLE TO BE HELD BY HOLDER AS THE POST ON THE BACK HAS ROUNDED OFF EDGES OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807790 ↗
• 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 15278016 ↗
• MalfunctionMay 4, 2022Scratched Material; Scratched Material

  INSTRUMENT IS SCRAPPED AND CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278504 ↗