Arthrex® AR-9297-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867350038), received between Nov 17, 2023 and Feb 20, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 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-9297-15 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 24401093 ↗
• MalfunctionAug 1, 2025Naturally Worn; Naturally Worn

  ON 07/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9297-15 REAMER SLEEVE AND AR-9676 REAMER ARE VISIBLY WORN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686965 ↗
• MalfunctionApr 3, 2025Fitting Problem; Physical Resistance/Sticking; Fitting Problem; Physical Resistance/Sticking

  ON 03/14/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9297-15 AVL ANGLED REAMER SLEEVE ASSEMBLY INNER SHAFT WILL NO LONGER FIT. NO ADDED TIME OR ADVERSE EVENT OCCURRED. THE CASE WAS COMPLETED WITH A SECOND DRIVER FROM THE SET. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764680 ↗
• MalfunctionMar 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 02/19/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN (2) AR-9297-15 UNIVERS VAULTLOCK® AUGMENTED GLENOID ANGLED REAMER SLEEVES HEAT WELDED WITH THE AR-9676 ANGLED REAMERS. THIS OCCURRED DURING A TOTAL SHOULDER PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 21537265 ↗
• MalfunctionMar 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 02/19/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN (2) AR-9297-15 UNIVERS VAULTLOCK® AUGMENTED GLENOID ANGLED REAMER SLEEVES HEAT WELDED WITH THE AR-9676 ANGLED REAMERS. THIS OCCURRED DURING A TOTAL SHOULDER PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY

  Patient problems: Insufficient Information

  MAUDE report 21537247 ↗
• MalfunctionJan 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06070664 THAT AN AR-9297-15 AUGMENTED GLENOID ANGLED REAMER SLEEVE WOULD NOT ALLOW THE INNER SLEEVE TO FIT DOWN THE INNER SHAFT. THIS OCCURRED DURING AN ARTHROPLASTY TSA ECLIPSE ON (B)(6) 2023 WHEN IT WOULD GET HUNG UP AND, THEREFORE, WOULD NOT SPIN/REAM PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 21113227 ↗
• MalfunctionJul 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6/6/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06587988 THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT, AND AR-9297-15 UNIVERS VAULTLOCK AUGMENTED GLENOID ANGLED REAMER SLEEVES (PART OF SET AR-9579S MGS AUGMENTED GLENOID INSTRUMENT SET) WERE STUCK TOGETHER. THIS WAS DISCOVERED AFTER THE CASE DURING THE DISMANTLING OF THE SETUP, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671350 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 2/04/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER AND AN AR-9297-15 ANGLED REAMER SLEEVE HEAT WELDED TOGETHER DURING A TOTAL SHOULDER PROCEDURE. THE PATIENT HAD EXTREMELY HARD BONE. THE PHYSICIAN WAS USING THE ANGLED REAMER TO PREPARE FOR THE 15 DEGREE VAULTLOCK IMPLANT, BUT WAS HAVING TO AN UNUSUAL AMOUNT OF FORCE IN ORDER TO GET THE CORRECTION HE NEEDED FOR THE IMPLANT TO SIT FLUSH. ONCE THE CASE WAS OVER AND THE TRAYS WERE PUT BACK TOGETHER IN SPD IT WAS REALIZED THAT THE INNER AND OUTER REAMER SLEEVES WERE ESSENTIALLY HEAT WELDED TOGETHER. THIS DID NOT AFFECT THE FLOW OR OUTCOME OF THE CASE, AS IT DID NOT CHANGE THE PERFORMANCE OF THE REAMER INTRA-OPERATIVELY.

  Patient problems: Insufficient Information

  MAUDE report 19492318 ↗
• MalfunctionJun 5, 2024Mechanical Jam; Mechanical Jam

  ON 08/05/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-9676 DRIVER SHAFT AND AR-9297-15 REAMER SLEEVE BECAME STUCK TOGETHER. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED USING A BACKUP TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470337 ↗
• MalfunctionMay 26, 2024Mechanical Jam; Mechanical Jam

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9297-15 ANGLED REAMER SLEEVE, AND AN AR-9676 DRIVE SHAFT COLD WELDED TOGETHER. THIS OCCURRED DURING AN AUGMENTED VAULTLOCK ON (B)(6)2023. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 05/16/2023, IT WAS REPORTED THAT SUFFICIENT REAMING HAD BEEN PERFORMED BEFORE THE DEVICE FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398862 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 07/01/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT DURING AN ARTHROPLASTY PROCEDURE A AR-9676 REAMER, AND A AR-9297-15 REAMER SLEEVE COLD WELDED TOGETHER. ALSO A AR-9239AG DRILL WAS FOUND TO HAVE A PIECE OF METAL CHIPPED. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS PROVIDED ON 07/07/2022, IT WAS REPORTED THAT THE AR ¿ 9239 AG DID NOT CHIP INSIDE THE BODY, AFTER THE DRILLING WAS COMPLETE THE TECH PUT THE DRILL ON THE TABLE AND IT FELL OFF ONTO THE FLOOR AND THIS CAUSED THE CHIP IN THE DRILL BITS. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387894 ↗
• MalfunctionMay 10, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON (B)(6) 2024 ADDITIONAL INFORMATION WAS RECEIVED BY A SALES REPRESENTATIVE VIA EMAIL WHO STATED THAT THE PROCEDURE BEING PERFORMED WAS AN ANATOMIC TOTAL SHOULDER REPLACEMENT. THE REAMER SHAFT COLD WELDED TO THE OUTSIDE ANGLED REAMER. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT AND AN ARTHREX REP WAS PRESENT AT THE TIME. THE PATIENT'S BONE QUALITY WAS ADEQUATE. NO PHOTOS WERE TAKEN AND A DIFFERENT REAMER WAS USED TO COMPLETE THE CASE. (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19293729 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  ON 4/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9297-15 ANGLED REAMER IS DAMAGED (NON-SPECIFICALLY). THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201692 ↗
• 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 18951544 ↗
• 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 18951516 ↗
• MalfunctionFeb 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 01/19/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER WAS WELDED TOGETHER WITH AN AR-9297-15 AUGMENTED GLENOID ANGLED REAMER SLEEVE. THIS OCCURRED DURING A CASE WHILE REAMING THE GLENOID THE ANGLED REAMER DRIVER SHAFT WELDED TOGETHER WITH THE ANGLED REAMER SLEEVE. THIS CAUSED THE SURGEON'S WRIST TO SUDDENLY TWIST AND MADE THE REAMING DIFFICULT. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT REAMER SLEEVE AND DRIVESHAFT.

  Patient problems: Insufficient Information

  MAUDE report 18659363 ↗
• MalfunctionNov 17, 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 18158613 ↗