Arthrex® AR-9597-10Recalls & reported problems
Arthrex, Inc. · ANGLED REAMER SLEEVE, 10° · Class 1
Quick summary
This Arthrex angled reamer sleeve, a surgical tool used in shoulder surgery, has 106 reports, with no deaths and no injuries. Many reports describe the sleeve sticking or fusing to its drive shaft so the reamer would not spin freely, and some describe a bent sleeve or shaft. Reports fell from 21 in the prior 12 months to 2 in the latest 12 months. No recalls name 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
- 106
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 00888867343436), received between Aug 17, 2023 and Mar 19, 2026 — classified as 106 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (84 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking84
- Mechanical Jam8
- Device Damaged by Another Device3
- Material Twisted/Bent3
- Defective Device2
- Crack1
- Device Dislodged or Dislocated1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- Insufficient Information17
Recent adverse event reports
The 25 most recent of 106 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2026Physical Resistance/Sticking
ON 27-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 REAMER SLEEVE AND AN AR-9676 DRIVE SHAFT ARE FUSED TOGETHER. NO CASE INVOLVEMENT. IT WAS FURTHER REPORTED VIA (B)(4) THAT THIS OCCURRED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639880 ↗MalfunctionNov 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/31/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-10, 10-DEGREE ANGLED REAMER SLEEVE WAS COLD-WELDED TO AN AR-9676 ANGLED REAMER DRIVE SHAFT. THEY CONFIRMED BEING UNSURE OF THE TYPE OF PROCEDURE PERFORMED, BUT THE EVENT WASN¿T NOTICED IN THE CASE, AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534530 ↗MalfunctionSep 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 08/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER DRIVE SHAFT WERE WELDED TOGETHER AND DID NOT SPIN FREELY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031630 ↗MalfunctionJul 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 06/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED SLEEVE IS FUSED WITH THE DRIVE SHAFT. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385997 ↗MalfunctionJun 17, 2025Material Twisted/Bent; Material Twisted/Bent
ON 05/22/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT AND AN AR-9597-10 ANGLED REAMER SLEEVE WERE BENT. THEY WERE DISCOVERED DURING THE CASE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22237848 ↗MalfunctionMay 1, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 04/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE, 10°, WOULD STICK TOGETHER WITH ANY PRODUCT THEY ADD INSIDE THE DEVICE. 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 21942650 ↗MalfunctionApr 23, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device
ON 04/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9678 ANGLED REAMER, ORIENTATION HANDLE AND AN AR-9597-10 ANGLED REAMER SLEEVE, 10° WERE NOT WORKING PROPERLY, AND THEY HAD TO REAM THE GLENOID BY HAND. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED. 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 21890661 ↗MalfunctionApr 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 04/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) AN AR-9676 ANGLED REAMER, DRIVE SHAFT WAS GETTING LOCKED UP INSIDE THE AR-9597-10 ANGLED REAMER SLEEVE, 10°. THEY WERE ABLE TO COMPLETE THE CASE 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 21861635 ↗MalfunctionMar 21, 2025Device Damaged by Another Device; Device Damaged by Another Device
ON 03/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676 ANGLE REAMER DRIVE SHAFT SPUN AND STRIPPED INSIDE THE AR-9597-10 ANGLE REAMER SLEEVE 10 DEGREES WHILE REAMING THE GLENOID. THEY HAD TO LEAVE THE GLENOID AS IT WAS. THE REVERSAL WAS COMPLETED IN FULL. IT DID ADD 5 MINUTES TO THE CASE. THIS WAS DISCOVERED DURING A REVERS PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/13/2025: THEY HAD TO LEAVE THE GLENOID AS IT WAS REAMED AND COULD NOT USE ANOTHER OPTION. THERE WAS NO REPORT OF ADVERSE EFFECTS ON OR AFTER THE SURGERY FOR THE PATIENT. THIS OCCURRED DURING AN RTSA PROCEDURE ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21664380 ↗MalfunctionMar 20, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON (B)(6)2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT, AND AN AR-9597-10 ANGLED REAMER SLEEVE, 10° COLD WELDED TOGETHER WHILE IN USE. THE SURGEON DEEMED THE GLENOID READY FOR IMPLANTS, MOVED ON, AND COMPLETED THE CASE SUCCESSFULLY. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6)2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/17/2025: THERE WAS NO CASE DELAY OR ADDED ANESTHESIA. THE SURGEON DID NOT USE EXTRA PARTS TO COMPLETE THE CASE BECAUSE THE SURGEON DEEMED THE GLENOID WAS READY FOR IMPLANTS. NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21655328 ↗MalfunctionMar 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 02/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9594-10 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER DRIVE SHAFT WERE COLD-WELDED TOGETHER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21584594 ↗MalfunctionMar 6, 2025Mechanical Jam; Mechanical Jam
ON 02/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE, 10° GOT HOT AND WILL BIND UP AND GET STUCK WITH THE AR-9676 ANGLED REAMER, DRIVE SHAFT. 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 21537456 ↗MalfunctionMar 6, 2025Mechanical Jam; Mechanical Jam
ON 02/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT WAS STUCK INSIDE AN AR-9597-10 ANGLED REAMER SLEEVE AND COLD WELDED TOGETHER. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21535617 ↗MalfunctionFeb 26, 2025Mechanical Jam; Mechanical Jam
ON 02/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE, 10° AND AN AR-9676 ANGLED REAMER, DRIVE SHAFT FUSED TOGETHER DURING SURGERY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21470949 ↗MalfunctionFeb 19, 2025Positioning Failure; Positioning Failure
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE, AND AN AR-9676 ANGLED REAMER NO LONGER FIT TOGETHER, OR SPIN AS NEEDED. THIS OCCURRED DURING A CASE, THE PATIENT WAS SUPPOSED TO HAVE A 10 DEGREE AUGMENTED BASEPLATE PER THE VIP, THEY HAD TO GO WITH A STANDARD BASEPLATE INSTEAD. OTHER THAN THAT, THERE WAS NO ADVERSE ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21412985 ↗MalfunctionFeb 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 01/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 REAMER SLEEVE AND AR-9676 DRIVE SHAFT ARE STUCK TOGETHER. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21376313 ↗MalfunctionFeb 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 01/27/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676 ANGLED REAMER HEAT WELDED INSIDE OF THE AR-9597-10 ANGLED REAMER SLEEVE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 21375987 ↗MalfunctionFeb 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 01/24/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE, AND AN AR-9676 ANGLED REAMER WERE BOUND UP. THIS OCCURRED DURING A REVERSE PROCEDURE WHEN THE INNER DRIVE SHAFT BOUND UP ON THE ANGLED REAMER SLEEVE AND WOULD NOT SEPARATE FROM THE SLEEVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 21374623 ↗MalfunctionJan 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 12/18/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06737551 THAT AN AR-9676 ANGLE REAMER, DRIVE SHAFT, AND AN AR-9597-10 ANGLE REAMER SLEEVE, 10°, SEIZED TOGETHER WHILE IN USE USING STANDARD TECHNIQUE WITH NORMAL BONE QUALITY. THE PATIENT WAS NOT HARMED. THE CASE WAS COMPLETED USING A DIFFERENT SET OF INSTRUMENTS. THIS WAS DISCOVERED DURING A PROCEDURE ON 12/12/2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21148842 ↗MalfunctionDec 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-10 REAMER SLEEVE AND AR-9676 DRIVE SHAFT ARE DAMAGED NON-SPECIFICALLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20902582 ↗MalfunctionNov 13, 2024Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 10/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER, AND AN AR-9597-10 ANGLED REAMER SLEEVE WELDED TOGETHER. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20678094 ↗MalfunctionNov 12, 2024Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 11/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06704586 THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AR-9676 ANGLED REAMER DRIVE SHAFT GOT STUCK TOGETHER AND COULD NOT BE PULLED APART. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20666917 ↗MalfunctionNov 6, 2024Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 10/23/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-9597-10 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER WELDED TOGETHER. THIS OCCURRED DURING A CASE AFTER REAMING. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20623992 ↗MalfunctionOct 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2024 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06682699 THAT AN AR-9676 ANGLED REAMER, DRIVE SHAFT WAS STUCK TOGETHER WITH AN AR-9597-10 ANGLED REAMER SLEEVE, 10° AFTER A CASE. THIS WAS NOTICED AFTER USE, WITH NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20494829 ↗MalfunctionOct 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/08/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-9597-10, TWO (QTY.2) AR-9597-20, AND TWO (QTY.2) AR-9676 ANGLED REAMER INSTRUMENTS ARE STICKING. THEY OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20464642 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.