Arthrex® AR-8933-18SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867210530), received between Mar 14, 2022 and Jul 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ARTRODESIS FOREFOOT SURGERY THE SURGEON PULLED OUT ONE 16 AND ONE 18 MILLIMETER SCREW (AR-8933-18S, LOT: 15225963), BUT THEY WERE BOTH 16 MM SCREWS IN THIS CASE. IT WAS WRONGLY MARKED. THE SURGEON USED ONE OF THE 16 MM SCREWS AND THREW AWAY THE OTHER (AR-8933-18S, LOT: 15225963), AS IT HAD ALREADY BEEN IN THE WOUND. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566841 ↗
• MalfunctionFeb 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE SCREWS INSERTED INTO PATIENT BUT HEAD OF SCREW SHEARED OFF. IT WAS FURTHER REPORTED THAT SHAFTS REMAINED IN PATIENT. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18808588 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED THAT DURING A METATARSOPHALANGEAL JOINTS (MTP JOINTS) SURGERY OF THE FIRST METATARSAL JOINT WHEN FILLING THE OBLONG HOLE ON THE STANDARD LEFT CONTOURED PLATE THE 3MM X 18MM CORTICAL SCREW HEAD SNAPPED AND THE SCREW WAS NOW NOT RETRIEVABLE FROM HOLE WITHOUT HEAD TO HOLD TO DRIVE OUT. THE SURGEON REPORTED THAT THERE WAS NO RESISTANCE FELT OR ANYTHING UNUSUAL PRIOR TO DRIVING SCREW INTO HOLE AND ALL CORRECT DRILL/ GUIDES WERE USED AS PER OPTECH AND INSTRUMENTATION SYSTEM. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18352112 ↗
• MalfunctionMar 14, 2022Break

  IT WAS REPORTED THAT DURING A TARSOMETATARSAL FUSION SURGERY USING THE 5 HOLE 3MM STRAIGHT PLATE THE SURGEON IMPLANTED A 3X18MM CORTICAL SCREW. WHEN TIGHTENING THE SCREW THE HEAD SHEERED OFF WITH A CLEAN BREAK. THE SURGEON WAS ABLE TO CONTINUE AND COMPLETE THE SURGERY BUT THE SCREW SHAFT WAS LEFT IN PLACE, NOT PROMINENTLY, BUT HE WAS UNABLE TO REMOVE IT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759028 ↗