Arthrex® AR-9236-01PPRecalls & reported problems
Arthrex, Inc. · UNIVERS VAULTLOCK GLENOID TRIAL, SMALL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex small Universal VaultLock glenoid trial is a temporary sizing component used during shoulder replacement surgery. The 35 reports mostly describe the trial breaking or cracking, in several cases while the surgeon was inserting or removing it, and once with the center post snapping off and fragments being retrieved from the patient. Reports describe no deaths and no injuries. There are no recalls naming 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00888867250673), received between Mar 29, 2021 and Sep 10, 2026 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Break” (36 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break36
- Crack1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Insufficient Information13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715948 ↗MalfunctionSep 19, 2025Break; Break
ON 08/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-01PP GLENOID TRIAL BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097098 ↗MalfunctionAug 11, 2025Break; Crack; Break; Crack
ON 07/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-01PP GLENOID TRIAL IS CRACKED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769987 ↗MalfunctionJun 26, 2025Break; Break
ON 06/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-01PP GLENOID TRIAL BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22336914 ↗MalfunctionFeb 18, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-01PP UNIVERS VAULTLOCK¿ GLENOID TRIAL BROKE. THIS OCCURRED DURING A SYRACUSE WHEN THE SURGEON WAS TRYING TO INSERT WITH FORCEPS. THERE WAS NO EXCESSIVE FORCE USED. THE CENTER POST WAS STILL HANGING ON BY A THREAD SO THE DOCTOR JUST PULLED IT OFF AND REINSERTED A TRIAL WITH A PEG AND KEEL. THERE WERE NO ISSUES, AND NO ADDED TIME.¿
Patient problems: Insufficient Information
MAUDE report 21399312 ↗MalfunctionDec 31, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE TRIAL GLENOID BROKE. 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 21048009 ↗MalfunctionSep 19, 2024Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 09/12/2024: THE CASE WAS COMPLETED WITHOUT INCIDENT, TRIALING HAD ALREADY OCCURRED AND WAS VERIFIED. THE INSTRUMENT DID NOT BREAK DURING INSERTION, BUT RATHER EXTRACTION.
Patient problems: Insufficient Information
MAUDE report 20259135 ↗MalfunctionJun 7, 2024Break; Break
ON 5/13/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT THE STEM OF AN AR-9236-01PP UNIVERS VAULTLOCK GLENOID TRIAL POLY BROKE DURING A TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. A PHOTO IS ATTACHED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484723 ↗MalfunctionApr 24, 2024Break; Break
ON 3/28/2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-9236-01PP UNIVERS VAULTLOCK GLENOID TRIAL CENTER PEG HAD BROKEN OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT WITHOUT ADVERSE EFFECTS ON THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-9236-01PP UNIVERS VAULTLOCK GLENOID TRIAL WITH NO ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171728 ↗MalfunctionMar 7, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9236-01PP GLENOID TRAY PEG BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. "THE CENTRAL PEG BROKE WHEN THE SURGEON WAS REMOVING THE TRIAL FROM THE PATIENT'S PREPPED GLENOID (SO THE PATIENT WAS INVOLVED). THE CENTRAL PEG WAS EASILY REMOVED FROM THE PATIENT AFTER IT BROKE OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856341 ↗MalfunctionFeb 20, 2024Break; Break
ON 2/1/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-01PP UNIVERS VAULTLOCK GLENOID TRIAL CENTRAL PEG BROKE OFF. THIS WAS DISCOVERED DURING THE REMOVAL OF THE TRAIL DURING A PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18739268 ↗MalfunctionJan 24, 2024Break; Break
ON 12/29/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-01PP UNIVERS VAULTLOCK GLENOID TRIAL BROKE DURING A CASE WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 1/16/2024: THE CENTER PEG OF THE VL TRIAL BROKE OFF INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. THE FAILURE OCCURRED WHEN THE TRAIL WAS TAKEN OUT OF THE PATIENT. THE CASE WAS NOT DELAYED. THIS WAS DISCOVERED DURING A ANATOMIC TOTAL SHOULDER ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18574310 ↗MalfunctionDec 20, 2023Break; Break
ON 11/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-01PP GLENOID TRIAL BROKE. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18362959 ↗MalfunctionSep 28, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06019570 THAT AN AR-9236-01PP UNIVERS VAULTLOCK GLENOID TRIAL CENTRAL PEG BROKE OFF DURING INSERTION. THE BROKEN FRAGMENT WAS RETRIEVED WITH PICKUPS, AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 17837829 ↗MalfunctionSep 1, 2023Break; Break
ON 08/07/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-01PP GLENOID TRIALS CENTRAL PEG BROKE OFF. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17669678 ↗MalfunctionAug 25, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-01PP UNIVERS VAULTLOCK GLENOID TRIAL, SMALL BROKE DURING A CASE UPON INSERTION INTO THE GLENOID. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17622669 ↗MalfunctionJul 24, 2023Break; Break
IT WAS REPORTED THAT DURING A PROSTHETIC SURGERY THE PIN OF THE TRIAL IMPLANT BROKE OFF. EVERYTHING WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17378755 ↗MalfunctionJul 6, 2023Break; Break
ON 06/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-01PP GLENOID TRIAL BROKE. THIS WAS DISCOVERED DURING A CASE, DEVICE BROKE DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECTS TO THE PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17272902 ↗MalfunctionJun 19, 2023Break; Break
ON 05/23/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-01PP GLENOID TRIAL BROKE WHEN BEING REMOVED. THIS OCCURRED DURING A TSA CASE WHEN BEING REMOVED THE DEVICE BROKE. THE BROKEN DEVICE WAS FULLY REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17152483 ↗MalfunctionJun 12, 2023Break; Break
ON 05/19/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-01PP GLENOID TRIAL BROKE DURING SURGERY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17112286 ↗MalfunctionFeb 13, 2023Break
IT WAS REPORTED ON 01/24/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-01PP AND AR-9236-02PP GLENOID TRIAL CENTER PEG BROKE OFF. CASE INVOLVEMENT, NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED CONFIRMATION VIA EMAIL, DEVICE BROKE DURING USE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16361802 ↗MalfunctionFeb 6, 2023Break
IT WAS REPORTED ON (B(6) 2023 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-9236-01PP GLENOID TRIAL CENTRAL PEG BROKE OFF. CASE INVOLVEMENT, DEVICE BREAKS DURING USE.
Patient problems: Insufficient Information
MAUDE report 16302883 ↗MalfunctionDec 12, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9236-01PP GLENOID TRIAL PEG BROKE OFF. THIS OCCURRED DURING TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2022 AFTER A SUCCESSFUL TRIAL WAS PERFORMED, THE SURGEON ATTEMPTED TO REMOVE THE CENTRAL PEG BROKE OFF. THE BROKEN PIECE OF THE TRIAL WAS THEN RETRIEVED. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15959601 ↗MalfunctionOct 17, 2022Break
ON 09/23/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9236-01PP GLENOID TRIALS CENTER PEG BROKE. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN CASE, WHEN REMOVING THE TRIAL FROM THE GLENOID. THE CENTER PEG WAS RETRIEVED, AND THERE WAS NOT PATIENT EFFECT REPORTED.
Patient problems: Insufficient Information
MAUDE report 15614900 ↗MalfunctionOct 3, 2022Break
ON 09/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9236-01PP GLENOID TRIAL BROKE. THIS OCCURRED DURING AN UNKNOWN CASE WHEN THE PEG BROKE OFF INSIDE THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15534437 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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