Arthrex® AR-9676Recalls & reported problems
Arthrex, Inc. · ANGLED REAMER, DRIVE SHAFT · Class 1
Quick summary
This Arthrex angled reamer drive shaft is a surgical tool used in orthopedic surgery. Most of its 209 reports describe the drive shaft and sleeve sticking or cold-welding together so the shaft does not spin freely, and some describe bent parts. The reports include no deaths or injuries. No recalls name this device. Only 1 report came in the last 12 months, versus 40 in the 12 months before.
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
- 209
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 00888867324954), received between Oct 30, 2023 and Nov 12, 2025 — classified as 209 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (181 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/Sticking181
- Mechanical Jam19
- Material Twisted/Bent5
- Defective Device3
- Separation Problem2
- Break1
- Device Dislodged or Dislocated1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions167
- Insufficient Information43
Recent adverse event reports
The 25 most recent of 209 reports, in the reporter's own words as published by the FDA.
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 23534762 ↗MalfunctionSep 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 08/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (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 23031842 ↗MalfunctionAug 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07010298 THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT DID NOT SPIN WITHIN THE SLEEVE. THE REAMER WAS REMOVED AND THE DRIVE SHAFT WAS LUBED AGAIN AND REINSERTED IN THE ANGLED REAMER SLEEVE. THE SURGEON WAS ABLE TO COMPLETE THE CASE BUT THE REAMER DID NOT SPIN AS IT SHOULD. WITH THE REAMER NOT AGAINST BONE IT WOULD STOP SPINNING. THERE WERE VISIBLE GROOVES LEFT ON THE DRIVE SHAFT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22852541 ↗MalfunctionAug 20, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-07008221 THAT AN AR-9597-20 ANGLED REAMER SLEEVE, AND AN AR-9676 ANGLED REAMER COLD WELDED TOGETHER. THIS OCCURRED DURING A CASE, THEY WERE ABLE TO PULL THEM APART, BUT THEY ARE NOW BENT AND WILL NOT FIT TOGETHER PROPERLY THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22850324 ↗MalfunctionAug 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 07/16/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE WAS COLD WELDED WITH INSIDE OF THE REAMER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/21/25, THAT THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY. AFTER THE 20 DEGREE MGS AUGMENT REAMER MALFUNCTIONED, THE 25 DEGREE PRIMARY AUGMENT REAMER WAS USED TO COMPLETE REAMING. ADDITIONAL INFORMATION WAS PROVIDED, ON 7/24/25, THAT THE SLEEVE WAS STUCK TO THE DRIVE SHAFT. PART NUMBER AND SN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22717568 ↗MalfunctionAug 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9597-20 ANGLED REAMER SLEEVE WAS COLD-WELDED WITH AN AR-9676 ANGLED REAMER AND NO LONGER WORKS. THIS WAS DISCOVERED AFTER THE CASE. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713319 ↗MalfunctionJun 20, 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 WAS RECEIVED ON 04/25/2025: ON (B)(6) 2025, A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE WAS PERFORMED WITHOUT DELAYS OR COMPLICATIONS. A BACKUP SET WAS USED TO COMPLETE THE CASE. NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND THE PATIENT EXPERIENCED NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22299171 ↗MalfunctionJun 18, 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 22282541 ↗MalfunctionApr 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 04/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) 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 21862071 ↗MalfunctionMar 21, 2025Material Deformation; Material Deformation
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 21663815 ↗MalfunctionMar 20, 2025Mechanical Jam; Mechanical Jam
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 21655297 ↗MalfunctionMar 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 02/26/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS- (B)(4) THAT AN AR-9676 ANGLED REAMER BOUND UP TO THE EXTERNAL REAMER DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2025. THIS CAUSED ABOUT A 10-MINUTE DELAY.
Patient problems: Insufficient Information
MAUDE report 21606681 ↗MalfunctionMar 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-9676 ANGLED REAMER BOUND UP TO THE EXTERNAL REAMER DURING A REVERSE TOTAL SHOULDER ON (B)(6) 2025. THIS CAUSED ABOUT A 10-MINUTE DELAY.
Patient problems: Insufficient Information
MAUDE report 21606600 ↗MalfunctionMar 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 02/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9597-20 REAMER SLEEVE AND AR-9676 REAMER SHAFT ARE WELDED TOGETHER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21597021 ↗MalfunctionMar 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 02/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06790695 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 21594735 ↗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 21537445 ↗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 21537223 ↗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 21537024 ↗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 21535616 ↗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 21470932 ↗MalfunctionFeb 24, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 02/11/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4). THAT AN AR-9597-20 ANGLED REAMER SLEEVE AND AN AR-9676 ANGLED REAMER BOUND UP INTERNALLY AND SUBSEQUENTLY BECAME COLD WELDED. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2025 THE INSTRUMENTS EXHIBITED AN UNEXPECTED MECHANICAL FAILURE, WHEREIN THEY BOUND UP INTERNALLY AND SUBSEQUENTLY BECAME COLD-WELDED, RENDERING THEM NON-FUNCTIONAL. THE MALFUNCTION WAS IDENTIFIED INTRAOPERATIVELY, REQUIRING THE SURGICAL TEAM TO OPEN A SECONDARY TRAY TO COMPLETE THE PROCEDURE. WHILE NO PATIENT HARM WAS SUSTAINED, THE ATTENDING SURGEON EXPRESSED SIGNIFICANT DISSATISFACTION WITH THE EVENT. THE FAILURE OF THE INSTRUMENTS LED TO OPERATIONAL INEFFICIENCIES AND PROCEDURAL DELAYS, IMPACTING THE OVERALL WORKFLOW OF THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447631 ↗MalfunctionFeb 21, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON 02/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT AND AN AR-9597-20 ANGLED REAMER SLEEVE FUSED TOGETHER. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE AND WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432153 ↗MalfunctionFeb 20, 2025Positioning Failure; Positioning Failure
ON 02/05/2025, 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 21420641 ↗MalfunctionFeb 19, 2025Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676 ANGLED REAMER WOULDN'T SLIDE SMOOTHLY WITH THE AR-9597-20 ANGLED REAMER SLEEVE. THIS OCCURRED DURING A CASE, WHILE REAMING THE GLENOID THE ANGLED REAMER DRIVER SHAFT DIDN'T SLIDE SMOOTHLY WITH THE ANGLED REAMER SLEEVE ON POWER. THIS JERKED THE SURGEON'S WRIST CAUSING REAMING TO BE DIFFICULT. THESE INSTRUMENTS WERE PUT TO THE SIDE AND A BACK UP TRAY WAS OPENED. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21412971 ↗MalfunctionFeb 19, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9676 ANGLED REAMER WAS DIFFICULT TO GET INTO THE AR-9597-20 ANGLED REAMER SLEEVE. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER PROCEDURE WHEN THE SURGEON BEGAN TO REAM THE DEVICES EVENTUALLY STOPPED MOVING. THE REPRESENTATIVE HAD TO BEAT THE DRIVER SHAFT TO GET IT OUT OF THE REAMER SLEEVE.
Patient problems: Insufficient Information
MAUDE report 21410473 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.