Arthrex® AR-5028P-08Recalls & reported problems
Arthrex, Inc. · INTSCRW RD DELTATPR W/DISP SHTH 8X28MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867035379), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-5028P-08, ROUND DELTA TAPERED PEEK INTERFERENCE SCREW, WITH DISPOSABLE SHEATH, 8 MM X 28 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-5028P-08. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714733 ↗
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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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