Arthrex® AR-9530XS-03Recalls & reported problems
Arthrex, Inc. · Trial Humeral Insert XS/33 +3mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867406582), received between May 1, 2025 and Apr 8, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Break
ON 17-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530XS-03 HUMERAL INSERT TRIAL WAS BROKEN. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT INVOLVEMENT OR HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818987 ↗MalfunctionFeb 11, 2026Break
ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530XS-03 HUMERAL INSERT TRIAL WAS DAMAGED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312637 ↗MalfunctionDec 11, 2025Break; Break
ON 11/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9530XS-03 HUMERAL TRIAL SNAPPED IN HALF DURING A CASE. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777091 ↗MalfunctionMay 1, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-9530XS-03 TRIAL, HUMERAL INSERT ARE BROKEN AROUND THE HOLES. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945302 ↗MalfunctionMay 1, 2025Break; Break
ON 04/14/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-9530XS-03 TRIAL, HUMERAL INSERT ARE BROKEN AROUND THE HOLES. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945290 ↗
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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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