Arthrex® AR-9236-02PPRecalls & reported problems
Arthrex, Inc. · UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex Univers Vaultlock glenoid trial is a shoulder implant trial used during joint replacement. The 77 adverse event reports mostly describe plastic trial parts breaking or cracking during surgery, sometimes leaving fragments that were retrieved; there is one reported injury and no deaths. There are no recalls on this device. Reports fell to 3 in the last 12 months from 11 in the previous 12 months.
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
- 77
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00888867250680), received between Aug 5, 2020 and Apr 10, 2026 — classified as 1 injury, 76 malfunctions.
The most frequently reported specific device problem is “Break” (72 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
- Break72
- Crack4
- Device Damaged by Another Device1
- Material Deformation1
- Material Fragmentation1
- Material Twisted/Bent1
- Positioning Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Insufficient Information24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Failure of Implant2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
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 24843576 ↗MalfunctionMar 18, 2026Material Fragmentation
ON 25-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-9236-02PP UNIVERS VAULTLOCK GLENOID TRIAL HAD PIECES FRAGMENT DURING A CASE AND WERE RETRIEVED. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625820 ↗MalfunctionJan 12, 2026Crack
ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP MEDIUM UNIVERS VAULTLOCK GLENOID TRIAL CRACKED DURING USE. THIS WAS DISCOVERED DURING AN ANATOMIC TOTAL SHOULDER ARTHROPLASTY - ECLIPSE WITH VAULTLOCK PROCEDURE WITH NO PATIENT HARM REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24036811 ↗MalfunctionSep 9, 2025Break; Break
ON 08/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK GLENOID TRIAL SUPERIOR PEG SNAPPED UNDER NORMAL USAGE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23009663 ↗MalfunctionMay 19, 2025Break; Break
ON 04/14/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIAL BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2025. THE FRAGMENT WAS RETRIEVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22047517 ↗MalfunctionMar 21, 2025Break; Break
ON 03/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK GLENOID TRIAL HAD 1 OF THE 2 PEGS BREAK OFF DURING A CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662394 ↗MalfunctionMar 18, 2025Break; Break
ON 03/03/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS- (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIAL BROKE INTO TWO PIECES. THIS OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY WHEN THE SURGEON TOOK THE TRIAL POLY OUT IT BROKE INTO TWO PIECES. THE PATIENT WAS NOT HARMED AND NO PIECES WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633310 ↗MalfunctionMar 6, 2025Break; Break
ON 02/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP GLENOID TRIAL SNAPPED OFF AND BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21537147 ↗MalfunctionFeb 12, 2025Material Deformation; Material Deformation
ON 01/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-9236-02PP UNIVERS VAULTLOCK GLENOID TRIAL PEG WAS STRIPPED OFF. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21364589 ↗MalfunctionJan 8, 2025Break; Break
ON (B)(6)2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21102924 ↗MalfunctionDec 31, 2024Break; Break
ON 12/04/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT (QTY. (B)(4)) OF AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIAL, MEDIUM, WAS BROKEN. THE CASE WAS COMPLETED WITH A BACKUP TRIAL FROM ANOTHER SET AVAILABLE WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048854 ↗MalfunctionDec 31, 2024Break; Break
ON 12/04/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT (QTY. (B)(4)) OF AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIAL, MEDIUM, WAS BROKEN. THE CASE WAS COMPLETED WITH A BACKUP TRIAL FROM ANOTHER SET AVAILABLE WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048852 ↗MalfunctionNov 11, 2024Break; Break
ON 10/29/2024, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIAL PEG BROKE IN TWO PIECES WHEN TRYING TO REMOVE THE TRIAL FROM THE BONE WITH NO EXCESSIVE FORCE USED. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT, AND THE CASE WAS CONTINUED AND COMPLETED. THIS EVENT DID NOT AFFECT THE PATIENT. THIS WAS DISCOVERED DURING A LEFT TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652486 ↗MalfunctionNov 7, 2024Break; Break
ON 10/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK GLENOID TRIAL HAD THE CENTRAL PEG BREAK OFF. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20631742 ↗MalfunctionJun 4, 2024Break; Break
ON 05/07/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP GLENOID TRIAL BROKE WHILE TRIALING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19460945 ↗MalfunctionMar 7, 2024Break; Break
ON 02/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIALS CENTRAL PEG BROKE OFF. THIS OCCURRED DURING A TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WHEN THE SURGEON WAS REMOVING THE TRIAL FROM THE GLENOID, THE CENTRAL PEG BROKE OFF. HE WAS ABLE TO USE THE FORCEPS TO GET THE REMAINING CENTRAL PEG OF THE TRIAL OUT OF THE PATIENT. THERE WAS NO HARM TO THE PATIENT AND ALL PARTS OF THE TRIAL WERE ABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18858101 ↗MalfunctionFeb 21, 2024Break; Break
ON 2/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK GLENOID TRIAL CENTER PEG SNAPPED OFF AT THE BASE OF THE TRIAL WHILE REMOVING THE GLENOID TRIAL. THE SURGEON PULLED THE BROKEN CENTER PEG OUT WITH A DIFFERENT INSTRUMENT, AND THE CASE WAS CARRIED ON AND WAS COMPLETED SUCCESSFULLY SINCE THIS INSTRUMENT WAS FINISHED BEING USED. THIS WAS DISCOVERED DURING AN ATSA PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 2/9/2024: THERE WAS NO CASE DELAY AND THE BROKEN PEG WAS EASILY PULLED OUT OF THE PATIENT WITHOUT ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18750239 ↗MalfunctionFeb 21, 2024Break; Break
ON 2/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE UNIVERS VAULTLOCK GLENOID TRIAL, AR-9236-02PP, BROKE DURING A CASE. NO FURTHER DETAILS PROVIDED, ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 2/8: ALL FRAGMENTS REMOVED. CASE WAS COMPLETED AS SCHEDULED WITH NO ISSUES OR COMPLICATIONS. FAILURE OCCURRED DURING INSERTION. DEVICE WAS BELIEVED TO BE TOSSED BY CSP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18750071 ↗MalfunctionFeb 21, 2024Break; Break
ON 02/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING AN ATSA PROCEDURE, WHILE REMOVING THE GLENOID TRIAL, AR-9236-02PP, THE CENTER PEG SNAPPED OFF AT THE BASE OF THE TRIAL. THE SURGEON WAS ABLE TO PULL THE BROKEN CENTER PEG OUT WITH A DIFFERENT INSTRUMENT. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY SINCE THIS INSTRUMENT WAS DONE BEING USED. NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18750040 ↗MalfunctionFeb 21, 2024Break; Break
ON 01/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIALS CENTRAL PEG SNAPPED OFF. THIS OCCURRED DURING A TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WHEN THE CENTRAL PEG OF THE TRIAL SNAPPED OFF WHEN THE SURGEON WAS ATTEMPTING TO REMOVE IT FROM THE GLENOID. SINCE THEY WERE DONE USING IT AFTER THAT, THEY NO LONGER NEEDED IT DURING THAT CASE. THE SURGEON IMMEDIATELY FOUND THE BROKEN PIECE AND HANDED IT OFF TO THE SCRUB TECH ALONG WITH THE TRIAL ITSELF. THERE WAS NO DELAY IN THE CASE AND NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18747710 ↗MalfunctionNov 28, 2023Break; Break
ON 10/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06070363 THAT AN AR-9236-02PP UNIVERS VAULTLOCK¿ GLENOID TRIAL BROKE. THIS OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY ON 10/27/2023 WHEN THE VAULTLOCK TRIAL CENTRAL PEG BROKE UPON INSERTION DURING THE TRIAL PROCESS. THE PEG WAS ABLE TO BE REMOVED, AND THE IMPLANT WAS SUCCESSFULLY IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 18218783 ↗MalfunctionNov 1, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-02PP GLENOID TRIAL IS BROKEN. THERE WAS NO CASE INVOLVEMENT. ADDITIONAL INFORMATION WAS PROVIDED ON 06/07/2023, AND IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY CASE. THE DEVICE DID BREAK OFF INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18049311 ↗MalfunctionOct 18, 2023Break; Crack; Break; Crack
ON 9/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06036519 THAT AN AR-9236-02PP UNIVERS VAULTLOCK GLENOID TRIAL, MEDIUM, CRACKED. THIS HAPPENED DURING A CASE, BUT THEY USED AN INSTRUMENT FROM AN ALTERNATE TRAY. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/22/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: THIS OCCURRED DURING A TSA PROCEDURE ON (B)(6) 2023. A PIECE CRACKED AND BROKE OFF INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT, AND NO CASE DELAY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 10/2/2023, THE SALES REPRESENTATIVE STATED VIA EMAIL THAT THE COMPLAINT DEVICE CRACKED AND BROKE DURING THE INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17958778 ↗MalfunctionJul 12, 2023Break; Break
ON 06/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9236-02PP GLENOID TRIAL CENTRAL PEG BROKE OFF. THIS WAS DISCOVERED DURING A CASE, DEVICE BROKE DURING USE.
Patient problems: Insufficient Information
MAUDE report 17304480 ↗MalfunctionJul 12, 2023Break; Break
ON 06/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9215-1-03 QUICK CONNECT HANDLE TIP BROKE OFF IN THE DRILL GUIDE, A COKER WAS USED TO REMOVE DRILL GUIDE AFTER COMPLETION OF DRILLING. AND AN AR-9236-02PP GLENOID TRIAL CENTER PEG BROKE OFF DURING EXTRACTION AND WAS REMOVED WITH A COKER. A SIMILAR TRIAL WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A CASE AND DEVICE BROKE DURING USE.
Patient problems: Insufficient Information
MAUDE report 17304416 ↗
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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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