Arthrex® AR-8933HVCL-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867324435), received between Feb 28, 2022 and Feb 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (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

Recent adverse event reports

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

• InjuryFeb 28, 2022Contamination

  ON 02/14/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE PHONE THAT DURING AN MTP FUSION THE SURGEON INSERTED 4 SCREWS FROM THE STERILIZED CADDY. AFTER IMPLANTING THE SCREWS HE NOTICE THAT SOMETHING WAS INSIDE THE THREADS OF THE SCREWS. THE SALES REP STATED IT LOOKED LIKE THE CADDY WAS STERILIZED WITH THE SURGICAL LABELS INSIDE. CALLER WAS NOT IN THE CASE, DID NOT HAVE ALL THE DETAILS. ADDITIONAL INFORMATION 02/15/2022: ON 02/14/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE EMAIL THAT DURING AN MTP FUSION ON (B)(6) 2022, THE SURGEON IMPLANTED AR-9944S-0L COMPRESSION PLATE (LINE #1), AR-8933HVCL-14 KREULOCK SCREW (LINE#2), AR-9933HY-16 3.0 HYBRID SCREW (LINE#3), AND AR-8933HVCL-18 KREULOCK SCREW ( LINE#4) AFTER INSERTION AN UNKNOWN DEBRIS WAS DISCOVERED ON THE SHAFT OF THE SCREWS. THE SURGEON REMOVED ALL THREE SCREWS FROM THE PATIENT. NO FRAGMENT OR DEBRIS WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED BY USING AN ALTERNATIVE SYSTEM ADDING 30 MINUTES TO THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13621503 ↗