Arthrex® AR-8933L-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050112), received between Dec 15, 2016 and Jan 23, 2018 — classified as 3 injuries.

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 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.

• InjuryJan 23, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON HIS RIGHT FOOT ON (B)(6) 2017 WHERE A 4 MM PROXIMAL WEDGE PLATE ((B)(4)) AND A 3.5 MM HEADLESS SCREW FOR CHEVRON ((B)(4)) WERE IMPLANTED. ALSO IMPLANTED WAS A 2.4 HEADED SCREW FOR K-WIRE BUT REPORTER DOES NOT BELIEVE THIS IS AN ARTHREX PRODUCT. THE PATIENT BEGAN TO EXPERIENCE HEAT AND SWELLING IN HIS FOOT ABOUT 2 MONTHS POST-OP. THE SURGEON IS CONSIDERING REMOVING THE HARDWARE. PATIENT'S ONLY KNOWN DRUG ALLERGY IS TO NEOMYCIN ANTIBIOTIC OINTMENT. FOLLOW-UP INVESTIGATION: DATE OF SURGERY WAS (B)(6) 2017, PATIENT IS A MALE, SURGERY WAS ON RIGHT FOOT. PATIENT HAS SIGNIFICANT SWELLING TO DATE, 4.5 MONTHS AFTER SURGERY. DECISION TO REMOVE THE HARDWARE HAS NOT BEEN MADE. PATIENT IS STILL EXPERIENCING THE LOCALIZED HEAT AND SWELLING AT THE SURGICAL SITE. PART NUMBERS HAVE NOW BEEN OBTAINED AND THE MATERIAL COMPOSITION OF EACH IMPLANT HAS BEEN PROVIDED.

  Patient problems: Swelling

  MAUDE report 7211698 ↗
• InjuryJul 14, 2017Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPIDUS BUNIONECTOMY ON (B)(6) 2015 (B)(6) IN WHICH A PLATE AND 5 SCREWS WERE IMPLANTED IN HER LEFT FOOT. THE PATIENT BEGAN TO EXPERIENCE FOOT PAIN BEGINNING IN THE INCISION AREA AND RADIATING OUTWARD IN (B)(6) 2017. THE PATIENT IS SCHEDULED TO HAVE THE PLATE AND 5 SCREWS EXPLANTED ON (B)(6) 2017 AS THE BONE HAS FUSED. FOLLOW INVESTIGATION: SURGEON PERFORMED A SECOND SURGERY ON (B)(6) 2017 WHERE HE EXPLANTED THE FOLLOWING DEVICES WHICH HAD BEEN IMPLANTED DURING THE (B)(6) 2015 PROCEDURE: AR-8952TT-03 QTY1, AR-8933L-14 QTY 2, AR-8933L-12 QTY 2, AR-8933L-24 QTY1. THE PATIENT ALSO HAD AN AR-8730-34H FULLY THREADED MINI COMPRESSION SCREW FROM THE ORIGINAL PROCEDURE THAT THE SURGEON CHOSE TO LEAVE IN THE PATIENT. DURING THE (B)(6) 2017 SURGERY, THE SURGEON WAS USING A HEXALOBE DRIVER TO REMOVE THE SCREWS AND THE TIP OF THE DRIVER BROKE OFF. THE TIP WAS RETRIEVED WITH FORCEPS AND THE CASE WAS COMPLETED.

  Patient problems: Pain

  MAUDE report 6714805 ↗
• InjuryDec 15, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A PREVIOUS 2ND TMT FUSION ON (B)(6) 2015. THE SURGEON WAS PERFORMING A 2ND TMT FUSION REVISION SURGERY ON (B)(6) 2016 DUE TO NON-UNION DURING WHICH THE FOLLOWING DEVICES WERE EXPLANTED: AR-8952TT-04, LOT 6791406 (CC100071 LINE 177084), AR-8933L-24, LOT W38572 (CC100071 LINE 177085), AR-8933L-16, LOT 1437750 (CC100071 LINE 177086), AR-8933-26, LOT 157946 (QTY 2) (CC100071 LINE 177087) AND AR-8933-28, LOT 139580 (CC100071 LINE 177088). TO COMPLETE THE REVISION PROCEDURE THE SURGEON WAS IMPLANTING AN AR-8952MS-07, 2.4MM 7 HOLE LOW PROFILE STRAIGHT PLATE (CC100071 LINE 175374) ALONG WITH AN AR-8724L-18, 2.4MM X 18MM LOW PROFILE LOCKING SCREW (CC100071 LINE 175504) WERE BEING IMPLANTED IN THIS REVISION SURGERY. A 1.7MM DRILL WAS USED TO CREATE THE PILOT HOLES FOR THE SCREWS. THE SURGEON SECURED THE PLATE WITH BB TAKS. HE THEN INSERTED A 2.4MM LOCKING SCREW, AND THE SCREW HAD CUT THROUGH THE PLATE AND DID NOT LOCK IN. THE 2.4MM PLATE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3.0 MM STRAIGHT MTP PLATE AND SCREWS. NO PATIENT INJURY REPORTED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6178052 ↗