Arthrex® AR-9297-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867350045), received between Nov 16, 2023 and Feb 20, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Physical Resistance/Sticking

  ON 04-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT WHEN USING THE AR-9275T-L AUGMENTED VAULTLOCK REAMER, IT WOULD LOCK UP AND CATCH ON AN AR-9297-25 REAMER SLEEVE. THEY NEVER SWITCHED THE ACTUAL DISPOSABLE REAMER HEAD. THE ANATOMIC TOTAL SHOULDER PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401092 ↗
• MalfunctionFeb 20, 2026Physical Resistance/Sticking

  ON 04-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT WHEN USING THE AR-9275T-L AUGMENTED VAULTLOCK REAMER, IT WOULD LOCK UP AND CATCH ON AN AR-9297-25 REAMER SLEEVE. THEY NEVER SWITCHED THE ACTUAL DISPOSABLE REAMER HEAD. THE ANATOMIC TOTAL SHOULDER PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400852 ↗
• MalfunctionJun 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9597-20 (LINE #1) REAMER SLEEVE AND AN AR-9676 (LINE #2)REAMER SHAFT ARE WELDED TOGETHER. THIS WAS DISCOVERED DURING A PROCEDURE, AFTER A FEW SECONDS OF REAMING THE TWO BONDED TOGETHER SO THEY WERE MOVING AS ONE PIECE AND NOT INDEPENDENTLY. A SECOND AR-9676 (LINE #3) WAS OPENED TO FINISH THE CASE AND THEN PROCEEDED TO DO THE SAME THING.

  Patient problems: Insufficient Information

  MAUDE report 19563839 ↗
• MalfunctionJun 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9297-25 REAMER SLEEVE AND AR-9676 REAMER DRIVE SHAFT WERE STUCK TOGETHER AFTER A CASE. THIS WAS DISCOVERED AFTER A CASE WITH NO PATIENT EFFECT. WHEN FINISHING UP AN AUGMENTED VAULTLOCK TOTAL SHOULDER ARTHROPLASTY, A SCRUB TECH NOTED THAT HE COULD NOT SEPERATE THE DRIVE SHAFT FROM THE 25 DEGREE AUGMENTED REAMER HANDLE. WHEN INSTRUMENTS WERE PASSED OFF, I HAD TO USE A LOT OF FORCE TO GET THE PIECES SEPERATED, AND THE DISTAL END OF THE DRIVE SHAFT IS GOUGED INWARDS. THERE WAS NO DELAY IN SURGERY AND NO OTHER ADVERSE ISSUES. THERE WAS NO UNPLANNED INCISION. A SECOND SURGERY IS NOT NECESSARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492507 ↗
• MalfunctionMar 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9297-25 UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVE WAS LOCKING UP AND CAUSING ISSUES WHILE REAMING; THE INSIDE OF IT WAS NOT SMOOTH, AND THE INNER SLEEVE WAS NOT ABLE TO MOVE FREELY WITHIN THE ANGLED REAMER SLEEVE. THIS WAS DISCOVERED DURING A PROCEDURE (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 3/11/2024: THIS WAS DISCOVERED DURING A AUGMENTED ECLIPSE PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED BY USING AN ALTERNATIVE REAMER SLEEVE FROM A SEPARATE SET. THERE WAS NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960716 ↗
• MalfunctionMar 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 02/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA ()B(4) THAT AN AR-9297-25 AVL ANGLED REAMER SLEEVE ASSEMBLY, 25 AND AN AR-9676 ANGLED REAMER DRIVE SHAFT COLD WELDED AND WOULD NOT COME APART OUT OF THE AUGMENTED VAULTLOCK GLENOID INSTRUMENTS. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18953472 ↗
• MalfunctionMar 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-9223 GLENOID IMPACTOR HANDLE WOULD SLIDE DOWN AND (2) AR-9676 ANGLED REAMER, DRIVE SHAFT, (2) AR-9297-15 UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVE, (2) AR-9297-25 UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVE WERE WORN DOWN AND HAVING ISSUES WITH THE SHEATHS COLD WELDING. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951651 ↗
• MalfunctionMar 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 3/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-9223 GLENOID IMPACTOR HANDLE WOULD SLIDE DOWN AND (2) AR-9676 ANGLED REAMER, DRIVE SHAFT, (2) AR-9297-15 UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVE, (2) AR-9297-25 UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVE WERE WORN DOWN AND HAVING ISSUES WITH THE SHEATHS COLD WELDING. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951602 ↗
• MalfunctionFeb 1, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT DURING A PROCEDURE, WHILE REAMING THE GLENOID, THE ANGLED REAMER DRIVER SHAFT, AR-9676, WELDED TOGETHER WITH THE ANGLED REAMER SLEEVE, AR-9297-25. THIS CAUSED THE SURGEON'S WRIST TO SUDDENLY TWIST AND MAKES THE REAMING DIFFICULT. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT REAMER SLEEVE AND DRIVESHAFT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621269 ↗
• MalfunctionNov 16, 2023Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED ON 1/25/2024: THE ISSUE WITH THE INSTRUMENTS WAS DISCOVERED DURING INSPECTION PRIOR TO THE CASE STARTING. BACK UP SETS WERE USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18152383 ↗