GLOBAL APG+ 2230-00-025Recalls & reported problems
Depuy (Ireland) · GLOBAL APG+ STRAIGHT HANDLE OUTER · 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 10603295102984), received between Jul 19, 2017 and Mar 6, 2023 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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
Device problems
- Device-Device Incompatibility13
- Fitting Problem2
- Material Twisted/Bent2
- Naturally Worn2
- Peeled/Delaminated2
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions9
- No Code Available3
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE BLACK HANDLE PERIPHERAL DRILL GUIDE HOLDER WOULD NOT HOLD THE DRILL GUIDE. DISCOVERED BEFORE THE SURGERY BEGAN. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16486781 ↗MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT HANDLES WOULD NOT SECURELY HOLD ONTO BASEPLATE TEMPLATES. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579220 ↗MalfunctionOct 11, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT HANDLES WOULD NOT SECURELY HOLD ONTO BASEPLATE TEMPLATES. THERE WAS NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579181 ↗MalfunctionAug 25, 2022Device-Device Incompatibility; Device-Device Incompatibility
STRAIGHT HANDLE DRIVER WOULD NOT RETAIN GLENOID PERIPHERAL DRILL GUIDE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15299265 ↗MalfunctionAug 19, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE HANDLES WILL NOT HOLD METAGLENE ON. JUST FALLS OF. TIPS ARE WORN OUT. SURGICAL DELAY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15258026 ↗MalfunctionJun 3, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE WILL NOT STAY LOCKED INTO DRILL GUIDE, THE GUIDE FALLS RIGHT OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14596452 ↗MalfunctionNov 19, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE ITEMS ARE WORN AND NON OPERATIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12846260 ↗MalfunctionApr 28, 2021Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam
IT WAS REPORTED THAT THE THREADS STRIPPED ON BLACK HANDLE IN THE APG PAN AND TWO PARTS WERE STUCK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11739668 ↗MalfunctionApr 19, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent
IT WAS REPORTED THAT THE GLENOID PERIPHERAL GUIDE HANDLE AND GUIDE WAS FOUND TO HAVE BEEN WORN UPON INSPECTION, NOT HOLDING THE GUIDE WELL. PLEASE SHIP REPLACEMENTS TO (B)(6) FOR P1 TUESDAY (B)(6)..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11685456 ↗MalfunctionNov 13, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE STRAIGHT HEX DRIVER WOULD NOT ENGAGE IN GLENOID PREP APG PLUS GUIDE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10837688 ↗MalfunctionOct 22, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL HANDLE WAS HARD TO PLACE IN THE HOLE OF THE PERIPHERAL GUIDE AND WOULD FALL OFF WHILE POSITIONING ON THE GLENOID. THE SURGEON ASKED FOR IT TO BE REPLACED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10723128 ↗MalfunctionJan 10, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVERS WOULD NOT SECURELY HOLD THE DRILL TEMPLATE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9577504 ↗MalfunctionJan 10, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVERS WOULD NOT SECURELY HOLD THE DRILL TEMPLATE. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9577476 ↗MalfunctionSep 17, 2019Fitting Problem; Device-Device Incompatibility; Fitting Problem; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE CASE, THEY HAD TROUBLE WITH THE APG+ STRAIGHT HANDLE HEX DRIVER ATTACHED AND HOLDING THE PERIPHERAL DRILL GUIDE. IT WOULD KEEP COMING OFF. BOTH INSTRUMENTS NEEDS TO BE REPLACED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9079189 ↗MalfunctionDec 21, 2018Peeled/Delaminated; Peeled/Delaminated
REPORTED TRAY WITHIN A GRAPHIC CASE WAS DELAMINATING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8190296 ↗MalfunctionDec 21, 2018Peeled/Delaminated; Peeled/Delaminated
REPORTED TRAY WITHIN A GRAPHIC CASE WAS DELAMINATING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8190291 ↗MalfunctionDec 13, 2018Inadequacy of Device Shape and/or Size; Fitting Problem; Inadequacy of Device Shape and/or Size; Fitting Problem
MalfunctionSep 13, 2018Device-Device Incompatibility; Device-Device Incompatibility
HANDLE (2230-00-025) WOULD NOT FIT INTO EITHER RASP GUIDE 2230-10-282 OR PERIPHERAL DRILL GUIDE (2230-00-081). THIS FORCED THE SURGEON TO USE KOCHERS TO SET THE GUIDES WHICH LACKED STABILITY WHILE PERFORMING SURGICAL STEPS ASSOCIATED WITH EACH PIECE. THIS CAUSED 10 MINUTES OF ADDITIONAL SURGICAL TIME.
Patient problems: No Code Available
MAUDE report 7872213 ↗MalfunctionSep 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE METAL PARTS INSIDE THE INNER THREADED ROD AND HANDLE PARTIALLY DISLODGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7852316 ↗MalfunctionDec 29, 2017Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE APG+ HANDLE WILL NO LONGER HOLD APG DRILL GUIDE ANYMORE. NO SURGICAL DELAY. NO PIECES BROKEN LEFT IN PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7154389 ↗MalfunctionJul 19, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE BLACK SCREWDRIVER USED TO HOLD THE PERIPHERAL SCREW GUIDE WAS STRIPPED SO THE GUIDE WOULD NOT ATTACHED AND USED THE BLUE SCREW DRIVER FROM THE DELTA KIT.
Patient problems: No Code Available
MAUDE report 6725656 ↗
Other Orthopedic manual surgical instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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.
How reports and recalls are matched · Editorial policy · Report an error on this page