Arthrex® AR-5028P-09Recalls & reported problems
Arthrex, Inc. · INTSCRW RD DELTATPR W/DISP SHTH 9X28MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867035386), received between Jun 10, 2024 and Jun 10, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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
- Patient Device Interaction Problem1
Patient problems
- Damage to Ligament(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
ON 14TH MAY 2024 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT WHEN AN AR-5028P-09, ROUND DELTA TAPERED PEEK INTERFERENCE SCREW, WITH DISPOSABLE SHEATH, 9 MM X 28 MM WAS USED, THE LIGAMENT WAS CUT APART WHILE THE ANCHOR WAS INSERTED. THE ANCHOR WAS RETRIEVED. THIS WAS DETECTED DURING USE IN A RECONSTRUCTION OF THE POSTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER BRAND'S PRODUCT WAS USED. THE PROCEDURE WAS DELAYED FOR 1 HOUR AND NO ADDITIONAL ANESTHESIA WAS USED. BONE QUALITY WAS GOOD.
Patient problems: Damage to Ligament(s)
MAUDE report 19497148 ↗
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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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