Arthrex® AR-9215-1-03Recalls & reported problems
Arthrex, Inc. · QUICK CONNECT HANDLE, ASSEMBLY · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex Quick Connect Handle is a surgical instrument used to attach to guides during shoulder procedures. Its 68 reports almost all describe the handle or its tip snapping off mid-operation, sometimes leaving a piece behind in the guide or in the patient that had to be retrieved, and causing brief delays to the operation. There are no deaths and no reported injuries, and no recalls name this device. Reports dropped sharply, from 26 in the prior 12 months to 3 in the last 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
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00888867350021), received between Apr 18, 2022 and Aug 19, 2026 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Break” (68 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
- Break68
- Material Fragmentation1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions60
- Insufficient Information11
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326959 ↗MalfunctionApr 8, 2026Break
ON 16-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE SNAPPED AT THE BOTTOM WHEN CONNECTED TO THE GUIDE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 23-MAR-2026: IT WAS FURTHER REPORTED THIS WAS DISCOVERED DURING A TSA/ECLIPSE TOTAL SHOULDER PROCEDURE THAT WAS COMPLETED WITH ANOTHER QUICK CONNECT HANDLE. A ONE-MINUTE DELAY WAS EXPERIENCED AND ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816964 ↗MalfunctionMar 9, 2026Break
ON 13-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE BROKE DURING USE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 17-FEB-2026: IT WAS FURTHER REPORTED THIS OCCURRED DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE. WHEN THE DEVICE WAS INSERTED INTO THE GUIDE, IT SNAPPED AND BROKE OFF INTO THE GUIDE. THE SURGEON HAD TO REMOVE THE BROKEN PIECE OUT FROM THE PATIENT. NO EXTRA ANESTHESIA WAS ADMINISTERED, AND THE PATIENT WAS NOT HARMED. THE CASE WAS COMPLETED WITH ANOTHER QUICK CONNECT HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24550541 ↗MalfunctionMar 2, 2026Break
ON 10-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4). THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE DID NOT FUNCTION PROPERLY AND BROKE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 12-FEB-2026: IT WAS FURTHER REPORTED THE TIP OF THE DEVICE BROKE OFF, AND THE FRAGMENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THIS OCCURRED DURING A TSA PROCEDURE WITH A 10-MINUTE CASE DELAY EXPERIENCED. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED AS AN RTSA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482146 ↗MalfunctionJul 22, 2025Break; Break
ON 06/30/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLES DISTAL PIECE IN THE VAULTLOCK GUIDE SNAPPED OFF WHEN DRILLING INFERIOR KEEL HOLES. THIS OCCURRED DURING A CASE ON (B)(6) 2025, WHERE THERE WAS NO PATIENT HARM OR DELAY IN THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22568359 ↗MalfunctionJun 13, 2025Break; Break
ON 05/20/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE TIP BROKE WHEN REMOVING THE DRILL GUIDE FROM THE BONE AFTER FINISHING GLENOID PREP. THE BROKEN TIP WAS RETAINED IN THE DRILL GUIDE, WHICH WAS THEN REMOVED USING FORCEPS. THE GLENOID IMPLANT WAS THEN IMPLANTED WITHOUT SIGNIFICANT DELAY. THE PATIENT WAS UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205475 ↗MalfunctionJun 3, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE THAT CONNECTS TO TRIAL IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135042 ↗MalfunctionMay 28, 2025Break; Break
ON 05/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE TIP BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THERE WAS A MINOR DELAY TO THE CASE TO RECOVER THE PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22098492 ↗MalfunctionMay 28, 2025Break; Break
ON 05/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-9215-1-03 QUICK CONNECT HANDLES ARE BROKEN NON-SPECIFICALLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095637 ↗MalfunctionMay 28, 2025Break; Break
ON 05/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT TWO AR-9215-1-03 QUICK CONNECT HANDLES ARE BROKEN NON-SPECIFICALLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095607 ↗MalfunctionMay 27, 2025Break; Break
ON 05/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE AND AR-9231-01AG-25L DRILL GUIDE BROKE AS THE SURGEON WAS DRILLING THE SUPERIOR AND INFERIOR VAULT LOCK HOLES INTO THE GLENOID AND UPON REMOVAL THE KNURLED HANDLED SNAPPED OFF INSIDE OF THE VAULT LOCK DRILL GUIDE. BOTH PIECES WERE RETRIEVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THERE WAS NO DELAY TO THE CASE AS THE SURGEON HAD JUST FINISHED DRILLING ALL THE HOLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22090934 ↗MalfunctionMay 21, 2025Break; Material Fragmentation; Break; Material Fragmentation
ON 05/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE TIP BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE BROKEN PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22062651 ↗MalfunctionApr 4, 2025Break; Break
ON 03/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE BROKE WHILE REMOVING THE GLENOID TARGETER FROM OVER THE GUIDEWIRE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE BROKEN PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21771903 ↗MalfunctionApr 3, 2025Break; Break
ON 03/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE BROKE DURING USE WITH THE SECONDARY GUIDE DRILLING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/27/2025: THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO CASE DELAY REPORTED. THE BROKEN HANDLE WAS REPLACED USING ANOTHER HANDLE INCLUDED IN THE SET, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED. THIS OCCURRED DURING AN ANATOMIC TOTAL SHOULDER PROCEDURE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21765285 ↗MalfunctionMar 19, 2025Break; Break
ON 03/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21645165 ↗MalfunctionFeb 20, 2025Break; Break
ON FEBRUARY 7, 2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-06777612 THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE LOCKING PART BROKE OFF WHEN THE CUTTING BLOCK ROTATED DURING DRILLING. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 13, 2025: THIS OCCURRED DURING AN ECLIPSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2025. THEY USED AN ADDITIONAL HANDLE IN THEIR SETS TO COMPLETE THE CASE. A VAULTLOACK WAS USED TO COMPLETE THE CASE. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422200 ↗MalfunctionFeb 18, 2025Break; Break
ON 01/29/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE TIP OF THE INSTRUMENT BROKE OFF INSIDE OF THE PIECE THAT IS CONNECTS TO, AND AN AR-1999HH RATCHETING HANDLE BROKE AWAY WHEN ATTEMPTING TO TIGHTEN SUCH SCREWS; THE HANDLE DOES NOT HOLD ITS PLACE. THIS OCCURRED DURING USE WHERE BACKUP DEVICES WERE USED TO COMPLETE THE PROCEDURE WITHOUT DELAY OR COMPROMISE TO PATIENT CARE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21392795 ↗MalfunctionFeb 11, 2025Break; Break
THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21354228 ↗MalfunctionFeb 7, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE TIP BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED ON 1/22/25.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21335300 ↗MalfunctionFeb 7, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLES TIP BROKE SO IT WAS UNABLE TO CONNECT TO ANYTHING. THIS OCCURRED DURING A CASE, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21334250 ↗MalfunctionFeb 5, 2025Break; Break
ON 01/08/2025 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE ASSEMBLY BROKE OFF AND STAYED RETAINED WITHIN THE DRILL GUIDE. THIS WAS DISCOVERED DURING A TSA PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313693 ↗MalfunctionFeb 5, 2025Break; Break
ON 01/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE TIP BROKE OFF DURING A CASE. THE CASE WAS COMPLETED SUCCESSFULLY WITH AN AVAILABLE REPLACEMENT WITHOUT A CASE DELAY. 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 21313614 ↗MalfunctionFeb 5, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE WAS NOT WORKING AS INTENDED. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 01/16/2025: THE AR-9215-1-03 UNIVERSAL QUICK CONNECT HANDLE HAD THE TIP ON THE HANDLE SNAPPED OFF. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SECOND X2 HANDLE. THERE WAS NO CASE DELAY AND NO ADDED ANESTHESIA ADMINISTERED. THIS OCCURRED DURING A ATSA PROCEDURE ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21311350 ↗MalfunctionJan 23, 2025Break; Break
ON 12/30/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(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. 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 AN 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 21217403 ↗MalfunctionJan 22, 2025Break; Break
ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9215-1-03 QUICK CONNECT HANDLE ASSEMBLY VAULTLOCK GLENOID GUIDE HANDLE BROKE OFF. THIS WAS DISCOVERED DURING AN ANATOMIC SHOULDER REPLACEMENT WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21209498 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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