Arthrex® AR-5028P-10Recalls & reported problems
Arthrex, Inc. · INTSCRW RD DELTATPR W/DISP SHTH 10X28MM · Class 2 · Implant
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 00888867035393), received between Sep 13, 2018 and Dec 28, 2023 — classified as 2 malfunctions.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Patient-Device Incompatibility1
Patient problems
- Erythema1
- Insufficient Information1
- Pain1
- Swelling1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2023Break; Break
ON 08/23/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-5028P-10 PEEK WOULD NOT SEAT. THE SURGEON THEN REMOVED THE SCREW AND WHEN ATTEMPTING TO RE-INSERT THE SAME SCREW, THE DEVICE CRACKED BUT DID NOT SEPARATE FROM THE DEVICE. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED WITH A NEW AR-5028P-10.
Patient problems: Insufficient Information
MAUDE report 18410022 ↗MalfunctionSep 13, 2018Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT NEEDED TO HAVE THE DEVICES REMOVED POST-OP DUE TO INFECTION. ORIGINAL DOS (B)(6) 2018 FOR ACL WITH HAMSTRING AUTOGRAFT. PATIENT IS (B)(6) YO MALE, WHO PRESENTED WITH PAIN, REDNESS, SWELLING. A CULTURE SHOWED STAPH INFECTION AND THE DEVICES WERE REMOVED.
Patient problems: Erythema; Pain; Swelling; Unspecified Infection
MAUDE report 7873257 ↗
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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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