Arthrex® AR-9236-03PPRecalls & reported problems
Arthrex, Inc. · UNIVERS VAULTLOCK GLENOID TRIAL, LARGE · Class 2 · Implant
Quick summary
This Arthrex Univers Vaultlock glenoid trial is a shoulder sizing tool used during surgery. Most of the 80 reports describe the trial's pegs or plastic parts breaking, and a few mention fragments in the patient. The reports record no deaths and no injuries. Reports fell from 7 in the prior year to 2 in the latest year. No recalls name this device.
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
- 80
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00888867250697), received between Feb 9, 2021 and Jun 2, 2026 — classified as 80 malfunctions.
The most frequently reported specific device problem is “Break” (79 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break79
- Device Fell1
- Device Slipped1
- Difficult to Remove1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions43
- Insufficient Information33
- Foreign Body In Patient6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Break
ON 13-MAY-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP VAULTLOCK GLENOID CENTRAL PEG BROKE OFF IN THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT. ALL FRAGMENTS WERE RETRIEVED FROM WITHIN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361353 ↗MalfunctionApr 10, 2026Break
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY PLASTIC PARTS OF THE DEVICE BROKE. NO FRAGMENTS REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24838829 ↗MalfunctionOct 17, 2025Break; Break
ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK GLENOID TRIAL, LARGE HAD ITS MIDDLE PEG BREAK OFF DURING THE PROCEDURE. THE CASE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT AR-9236-03PP UNIVERS VAULTLOCK GLENOID TRIAL, LARGE. NO PATIENT HARM OR ADVERSE EFFECTS WERE REPORTED, AND NO PIECES WERE LEFT INSIDE THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324167 ↗MalfunctionSep 3, 2025Break; Break
ON 08/13/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE AND AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL WERE DAMAGED FROM HEAVY USE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 08/26/2025 WHERE IT WAS STATED THIS EVENT OCCURRED DURING AN ANATOMIC TOTAL SHOULDER CASE ON (B)(6) 2025. AN ATTACHMENT HANDLE WAS USED WITH THIS DEVICE. THE HANDLE SNAPPED AT THAT ATTACHMENT SITE OF THE DRILL GUIDE. A BACKUP SET USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 22950926 ↗MalfunctionMar 6, 2025Break; Break
ON 02/21/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL CENTRAL PEG BROKE OFF. THIS OCCURRED IN THE MIDDLE OF A CASE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21537484 ↗MalfunctionFeb 24, 2025Break; Break
ON (B)(6)2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP GELNOID TRIAL HAS A BROKEN PIECE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21446044 ↗MalfunctionFeb 19, 2025Break; Break
ON 02/04/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL BROKE. THIS OCCURRED DURING A CASE, DURING WHICH ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21410545 ↗MalfunctionFeb 5, 2025Break; Break
ON 01/10/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL, LARGE, HAD THE CENTER OF THE PEG BREAK OFF DURING TRIALING. IT WAS RETRIEVED EASILY FROM THE CENTER HOLE WITH A HEMOSTAT AND DID NOT CAUSE A CASE DELAY. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/13/2025:THE TRIAL CONFIRMED THE CORRECT PLACEMENT AND BROKE UPON REMOVAL. THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING AN TSA PROCEDURE ON (B)(6)2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312962 ↗MalfunctionJan 23, 2025Break; Break
ON 12/30/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL, AR-9231-VL-03 UNIVERS VAULTLOCK GLENOID DRILL GUIDE, AND AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE BROKE (SEE PHOTOS). NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING USE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/07/2024: THIS WAS DISCOVERED DURING A ANATOMIC TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY REPORTED AND NO ADVERSE EFFECTS ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 01/10/2025: THE AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL HAD THE CENTRAL POST BREAK OFF IN THE PATIENT AND WAS RETRIEVED. THE AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE HAD THE HANDLE TIP BREAK OFF INTO THE GLENOID DRILL GUIDE. AFTER FURTHER INVESTIGATION, AR-9231-VL-03 UNIVERS VAULTLOCK GLENOID DRILL GUIDE HAD NO DAMAGE FOUND. THE FAILURE OCCURRED DURING THE INSERTION OF THE AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218854 ↗MalfunctionOct 24, 2024Break; Break
ON 10/08/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK GLENOID TRIAL BROKE (SEE PHOTO ATTACHMENTS), WITH NO FURTHER INFORMATION PROVIDED. THE PATIENT WAS NOT HARMED BY THE BROKEN TRIAL. THIS WAS DISCOVERED DURING A SHOULDER ARTHROPLASTY PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20524557 ↗MalfunctionSep 6, 2024Break; Break
ON 08/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL MIDDLE PEG OF THE POLY BROKE OFF WHILE TRYING TO EXTRACT THE TRIAL. THIS OCCURRED DURING A TOTAL SHOULDER PROCEDURE, IT WAS INSIDE OF THE PATIENT BUT NOT DIFFICULT TO GET OUT. THE DOCTOR USED A HEMOSTAT TO PICK UP THE BROKEN PIECE.
Patient problems: Insufficient Information
MAUDE report 20158511 ↗MalfunctionJul 3, 2024Break; Break
ON 6/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK GLENOID TRIAL PEG BROKE OFF DURING AN RTSA PROCEDURE ON (B)(6) 2024. THERE WAS NO IMPACT TO THE PATIENT AND THE CASE WAS COMPLETED USING A BACKUP SET. THIS WAS DISCOVERED DURING USE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/11/2024: THIS OCCURRED PRIOR TO THE CASE WITH NOTHING BREAKING IN THE PATIENT. THERE WAS NO DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19671491 ↗MalfunctionJun 24, 2024Break; Break
ON 05/30/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL MIDDLE PIECE BROKE OFF THE TRIAL ONCE TAKEN OUT OF THE PATIENT. THIS OCCURRED DURING A ANATOMIC TOTAL SHOULDER CASE WHERE THERE WAS NO PIECE THAT FELL INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19599776 ↗MalfunctionJun 24, 2024Break; Break
ON 05/29/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIALS CENTRAL PEG SNAPPED OFF. THIS OCCURRED DURING A TSA PROCEDURE ON (B)(6) 2024 THE CASE WAS CARRIED ON SUCCESSFULLY AND THE BROKEN PEG WAS RETRIEVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19595947 ↗MalfunctionJun 18, 2024Break; Break
ON 05/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL L CENTER PEG BROKE. THIS OCCURRED WHILE TRIALING ON 05/23/2024 AND ALL FRAGMENTS WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 19562712 ↗MalfunctionJun 10, 2024Break; Break
IT WAS REPORTED THAT THE CENTRAL PEG ON THE AR-9236-03PP GLENOID TRIAL BROKE OFF UPON REMOVAL FROM THE PATIENT. THE BROKEN CENTRAL PEG WAS RETRIEVED AND VAULTLOCK IMPLANT WAS PUT INTO THE PATIENT. SEE SOURCE DATA ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19498018 ↗MalfunctionJun 6, 2024Break; Break
IT WAS REPORTED THAT THE CENTER PEG BROKE OFF DURING AN ECLIPSE SHOULDER CASE. THERE WAS NO MORE INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19477418 ↗MalfunctionJun 6, 2024Break; Break
IT WAS REPORTED THAT THE DURING A TSA PROCEDURE, WHEN REMOVING THE VAULTLOCK TRIAL FROM THE PATIENT WHEN TRIALING, THE CENTRAL PEG BROKE OFF THE BODY OF THE TRIAL. THE BROKEN PEG WAS RETRIEVED AND NO OTHER PIECES ARE MISSING FROM THE TRIAL - ALL COMPONENTS OF THE BROKEN DEVICE ARE ACCOUNTED FOR. AFTER THE MALFUNCTION, THE CASE CONTINUED AND WAS COMPLETED PER TECHNIQUE WITHOUT FURTHER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19477056 ↗MalfunctionMay 17, 2024Break; Break
ON 4/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4)THAT AN AR-9236-03PP UNIVERSE VAULTLOCK GLENOID TRIAL (LOT: S624TG000) HAD A CENTRAL PEG BREAK OFF AND WAS EASILY REMOVED FROM THE CENTRAL HOLE. THE CASE WAS COMPLETED BY OPENING AN ADDITIONAL TRIAL (LOT: S804TG000), AND THAT CENTRAL PEG STARTED TO BREAK BUT NOT COMPLETELY. THERE WAS A VISIBLE CRACK AROUND THE CENTRAL PEG, AND IT WAS LOOSE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT OR PIECES OF THE TRIAL LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING AN ECLIPSE PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 4/25/2024: THE AR-9236-03PP UNIVERSE VAULTLOCK GLENOID TRIAL (LOT: S624TG000) CENTRAL PEG ON THE TRIAL BROKE OFF DURING INSERTION OF THE TRIAL INTO THE PREPARED GLENOID. WHEN THE SECOND TRIAL (AR-9236-03PP UNIVERSE VAULTLOCK GLENOID TRIAL LOT: S804TG000) WAS REMOVED FROM THE PREPARED GLENOID THE SURGEON NOTICED THE CENTRAL PEG ON THE TRIAL WAS LOOSE AND THERE WAS A CRACK. THIS LIKELY OCCURRED DURING THE INSERTION OR REMOVAL OF THE TRIAL FROM THE PREPARED GLENOID. THE CASE WAS NOT DELAYED DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19345153 ↗MalfunctionMay 17, 2024Break; Break
ON 4/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4)THAT AN AR-9236-03PP UNIVERSE VAULTLOCK GLENOID TRIAL (LOT: S624TG000) HAD A CENTRAL PEG BREAK OFF AND WAS EASILY REMOVED FROM THE CENTRAL HOLE. THE CASE WAS COMPLETED BY OPENING AN ADDITIONAL TRIAL (LOT: S804TG000), AND THAT CENTRAL PEG STARTED TO BREAK BUT NOT COMPLETELY. THERE WAS A VISIBLE CRACK AROUND THE CENTRAL PEG, AND IT WAS LOOSE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT OR PIECES OF THE TRIAL LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING AN ECLIPSE PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 4/25/2024: THE AR-9236-03PP UNIVERSE VAULTLOCK GLENOID TRIAL (LOT: S624TG000) CENTRAL PEG ON THE TRIAL BROKE OFF DURING INSERTION OF THE TRIAL INTO THE PREPARED GLENOID. WHEN THE SECOND TRIAL (AR-9236-03PP UNIVERSE VAULTLOCK GLENOID TRIAL LOT: S804TG000) WAS REMOVED FROM THE PREPARED GLENOID THE SURGEON NOTICED THE CENTRAL PEG ON THE TRIAL WAS LOOSE AND THERE WAS A CRACK. THIS LIKELY OCCURRED DURING THE INSERTION OR REMOVAL OF THE TRIAL FROM THE PREPARED GLENOID. THE CASE WAS NOT DELAYED DUE TO THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19345116 ↗MalfunctionMay 8, 2024Break; Break
ON 04/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP LARGE GLENOID TRIAL BACK PEG SNAPPED OFF WHEN PULLING THE PART FROM THE GLENOID. THIS WAS DISCOVERED DURING DR. (B)(6) TOTAL SHOULDER ARTHROPLASTY PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19267479 ↗MalfunctionMar 28, 2024Break; Break
ON 3/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06512361 THAT AN AR-9236-03PP UNIVERS VAULTLOCK GLENOID TRIAL CENTRAL PEG BROKE OFF IN THE PATIENT. ALL BROKEN FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.
Patient problems: Insufficient Information
MAUDE report 18997779 ↗MalfunctionFeb 12, 2024Break; Break
ON 01/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERS VAULTLOCK¿ GLENOID TRIAL BROKE WHEN TRIALING. THIS OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE WHERE THE BROKEN FRAGMENT WAS NOT RECOVERED DUE TO HAVING TO DRILL IT OUT.
Patient problems: Foreign Body In Patient
MAUDE report 18685233 ↗MalfunctionJan 24, 2024Break; Break
ON 01/05/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-03PP UNIVERSE VAULTLOCK GLENOID TRIAL CENTRAL PEG BROKE DURING TRIALING. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18574709 ↗MalfunctionJan 19, 2024Break; Break
ON 12/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9236-03PP UNIVERS VAULTLOCK GLENOID TRIAL, LARGE BROKE DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18543790 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
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- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.