Arthrex® AR-9510-01Recalls & reported problems
Arthrex, Inc. · UNIVERS REVERS VERSION ROD · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867061620), received between Nov 27, 2024 and Dec 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2024Break; Break
ON 11/29/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9510-01 ARTHREX UNIVERS REVERS¿ VERSION ROD AND AN AR-9216-4 GLENOID REAMER/DRILL GLOVE PROTECTOR BROKE DURING USE. THE CASE WAS COMPLETED SUCCESSFULLY. NO PIECES BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21018699 ↗MalfunctionNov 27, 2024Break; Break
UPDATE KPILZ 03-DEZ-2024: FURTHER INFORMATION WERE RECEIVED THAT THE DEVICE BROKE DURING A SHOULDER PROTHESIS SURGERY. THE DEVICE BROKE OUTSIDE OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 20795674 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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