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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867324190), received between Jul 20, 2023 and Aug 7, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PHONE REPORT WAS RECEIVED FROM A PATIENT WHO UNDERWENT AN MTP JOINT ARTHRODESIS WITH DORSAL PLATE AND SCREW FIXATION ON (B)(6) 2024 FOR TREATMENT OF HALLUX RIGIDUS OF RIGHT FOOT. DURING THE PROCEDURE, A PLATE PRODUCT IDENTIFIED ONLY AS ¿MAX FORCE¿ WAS IMPLANTED. ON (B)(6) 2025, APPROXIMATELY SIX MONTHS POSTOPERATIVELY, THE PATIENT REPORTED EXPERIENCING A LOUD "POP" WHILE WALKING. RADIOGRAPHS TAKEN ON (B)(6) 2025 CONFIRMED THAT THE IMPLANTED PLATE HAD FRACTURED. REVISION SURGERY IS SCHEDULED FOR ON (B)(6) 2025 WITH THE SAME SURGEON AT THE ORIGINAL FACILITY. THE PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION. DURING A PHONE CALL WITH THE SALES REPRESENTATIVE ON 07/09/2025, IT WAS REPORTED THAT DURING THE ORIGINAL PROCEDURE ON (B)(6) 2024, THE SURGEON EXPRESSED CONCERN THAT THE JOINT HAD BEEN SIGNIFICANTLY SHORTENED FOLLOWING THE REAMING PROCESS. TO COMPENSATE AND RESTORE PROPER LENGTH, A LIFENET BONE DOWEL REVISION WAS ADDED, AND THE BONE WAS ADJUSTED ACCORDINGLY. THE PLATE WAS IMPLANTED OVER THE BONE DOWEL. APPROXIMATELY THREE WEEKS AGO, THE PATIENT EXPERIENCED A ¿POP¿ WHILE ENGAGED IN PHYSICAL ACTIVITY, DESCRIBED BY THE SALES REPRESENTATIVE AS POSSIBLY ¿OUT GA

  Patient problems: Failure of Implant

  MAUDE report 22741667 ↗
• InjuryMay 14, 2024Material Fragmentation; Material Fragmentation

  ON 4/15/2024, IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL/SURGEON VIA PHONE THAT AN UNKNOWN LOCKING SCREW WITH AN UNKNOWN LOT NUMBER HAD AN ISSUE DURING A FIRST MTP FUSION PROCEDURE ON (B)(6) 2024. WHEN THE SURGEON WAS USING THE FIRST MTP FUSION PLATE, A LOCKING SCREW WAS PUT IN AND HAD TO BE REPLACED BECAUSE IT WAS TOO LONG. ANOTHER SHORTER LOCKING SCREW WAS PUT IN, AND A CURLY PIECE OF METAL DEBRIS, LIKE A SHARP WIRE, SMALLER THAN AN EYELASH, SEPARATED FROM THE SCREW AND BROKE OFF INSIDE THE PATIENT, WHICH WAS INITIALLY NOT NOTICED. WHEN WASHING OUT THE WOUND, THE METAL PIECE STABBED THE SURGEON'S THUMB. WHEN WITHDRAWING HER HAND, THE METAL PIECE WAS STUCK IN HER THUMB, WENT THROUGH TWO GLOVES, AND PIERCED THE SURGEON'S SKIN. T HE SURGEON WASHED AND DISINFECTED HER HAND AND THEN PROCEEDED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. THERE WAS A CASE DELAY OF 45 SECONDS, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 4/16/2024, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA PHONE: AN AR-8944S-0R MAXFORCE MTP PLATE AND AN AR-9944S-0R VAL KREULOCK

  Patient problems: Exposure to Body Fluids

  MAUDE report 19316241 ↗
• MalfunctionJul 20, 2023Failure to Advance; Failure to Advance

  ON 06/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8933VCL-18 KREULOCK SCREW WOULD NOT THREAD IN THE PLATE, IT WOULD JUST SPIN. THIS OCCURRED DURING THE FIRST MTP FUSION ON (B)(6) 2023, A HOLE WAS DRILLED AND WHEN THEY TRIED TO INSERT THE SCREW IT WOULD NOT THREAD IT WAS JUST SPINNING. THE SCREW WAS REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER SCREW. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364128 ↗