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Arthrex® AR-8933-16PTRecalls & reported problems

Arthrex, Inc. · LO-PRO SCRW,TI,3X 16MMCANN,PT THD · 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 00888867049529), received between Aug 1, 2016 and Aug 1, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

Most reported problems

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 1, 2016Patient-Device Incompatibility

    IT WAS REPORTED BY PATIENT THAT SHE HAD SURGERY ON HER RIGHT FOOT (B)(6) 2012 FOR DECOMPRESSION, OSTEOTOMY AND BUNIONECTOMY OF HER GREAT TOE AND LITTLE TOE. DURING THE PROCEDURE THE FOLLOWING PARTS WERE IMPLANTED: AR-8930-10 (LOT 13578A) AND AR-8933-16PT (LOT 16E4Y). PATIENT REPORTS THAT SHE HAS BEEN HAVING REACTION SYMPTOMS SINCE SURGERY WHICH PHYSICIAN HAS BEEN TREATING OVER THE PAST SEVERAL YEARS. PATIENT REPORTS BLISTERS IN THE GREAT TOE AREA. PATIENT HAS A KNOWN NICKEL ALLERGY.

    Patient problems: Reaction

    MAUDE report 5837691 ↗

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Sources and updates

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