Arthrex® AR-9126RPRecalls & reported problems
Arthrex, Inc. · UNIVERSAL GLENOID PRIMARY REAMER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867057623), received between Aug 31, 2021 and Apr 15, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (7 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.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt7
- Break2
- Defective Device2
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT DURING A GLENOID CHANGE SURGERY A RING AT THE TIP OF THE DRILL BIT BROKE OFF. THE FRAGMENT STAYED ATTACHED TO THE DRILL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24884259 ↗MalfunctionJan 15, 2026Dull, Blunt
ON 30-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9126RP INSTRUMENT IS DULL. NOTICED DURING A CASE BUT ABLE TO BE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24083389 ↗MalfunctionJan 15, 2026Dull, Blunt
ON 30-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9126RP INSTRUMENT IS DULL. NOTICED DURING A CASE BUT ABLE TO BE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24083226 ↗MalfunctionJan 15, 2026Dull, Blunt
ON 30-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9126RP INSTRUMENT IS DULL. NOTICED DURING A CASE BUT ABLE TO BE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24083059 ↗MalfunctionJan 15, 2026Dull, Blunt
ON 30-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9126RP INSTRUMENT IS DULL. NOTICED DURING A CASE BUT ABLE TO BE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24082023 ↗MalfunctionJun 4, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT, DURING A TOTAL SHOULDER ARTHROPLASTY SURGERY, THE DEVICE WAS DULL. ACCORDING TO THE SURGEON, NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19457436 ↗MalfunctionMay 27, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THE TIP OF THE AR-9126RP IS DEFECTIVE AND SURGEONS ARE EXPERIENCING ISSUES PASSING THE COATED PORTION OF THE FLEXIBLE 2.8 NITINOL PINS THROUGH THE REAMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19401091 ↗MalfunctionApr 26, 2024Dull, Blunt; Dull, Blunt
IT WAS REPORTED THAT DURING A SHOULDER PROTHESIS SURGERY IT WAS NOTICED THAT THE REAMER IS TOO DULL. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19192646 ↗MalfunctionApr 24, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE SURGEON WAS HAVING TROUBLE WITH THE NEW NITINOL GUIDE PINS FITTING THROUGH THE AR-9126RP AND AR-9126RC POST REAMERS. REPLACING ONE OF THE PRIMARIES RESOLVED THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19171969 ↗MalfunctionAug 14, 2023Break; Break
ON 07/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9126RP GLENOID PRIMARY REAMER SHAFT SNAPPED OFF. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2023, THE DEVICE SNAPPED OFF ALMOST IMMEDIATELY WHEN THE BLADE TOUCHED THE BONE. THE BROKEN FRAGMENT WAS RETRIEVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17541263 ↗MalfunctionAug 31, 2021Dull, Blunt; Defective Device
IT WAS REPORTED THAT DURING SHOULDER PROSTHESIS SURGERY THE RING AT THE MILLING MACHINE IS DEFECTIVE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED. THIS IS NOW REPORTABLE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12393061 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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