Arthrex® AR-8840C-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867048072), received between Sep 27, 2023 and Feb 6, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE TO HAVE EXPERIENCED A TRIMALLEOLAR ANKLE FRACTURE OF THE RIGHT LEG. DURING THE INITIAL CONSULTATION ON (B)(6) 2022, THE PATIENT REQUESTED TITANIUM IMPLANTS DUE TO A NICKEL ALLERGY. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY AND HAD AN AR-8835-12 LOW PROFILE SCREW, TWO AR-8835-14 LOW PROFILE SCREWS, AN AR-8835-16 LOW PROFILE SCREW, AN AR-8835CL-10 KREULOCK COMPRESSION SCREW, TWO AR-8835CL-16 KREULOCK COMPRESSION SCREWS, TWO AR-8840C-45 LOW PROFILE SCREWS, AND AN AR-8943T-08 LOCKING THIRD TUBULAR PLATE IMPLANTED, ALL OF WHICH ARE COMPOSED OF STAINLESS STEEL. THERE WERE NO REPORTS OF ANY ISSUES DURING THE SURGERY. THREE MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE HEALING PROBLEMS, SWELLING, A CHANGE IN THE KNEE COLOR, AND THE ANKLE BECOMING HOT TO THE TOUCH. THE PATIENT WAS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME STAGE ONE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 BY THE SAME SURGEON TO HAVE ALL THE PREVIOUSLY IMPLANTED SCREWS AND PLATE REMOVED; NO NEW ARTHREX PRODUCTS WERE IMPLANTED. AFTER THE SURGERY, THE PATIENT WAS GIVEN A BOOT. DUE TO THE ALLERGIC REACTION TO THE IMPLANTS, THE PATIENT DEVELOPED DECREASED MOBIL

  Patient problems: Foreign Body Reaction

  MAUDE report 21322651 ↗
• InjuryFeb 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 1/14/2025, A PATIENT REPORTED VIA PHONE TO HAVE EXPERIENCED A TRIMALLEOLAR ANKLE FRACTURE OF THE RIGHT LEG. DURING THE INITIAL CONSULTATION ON (B)(6)2022, THE PATIENT REQUESTED TITANIUM IMPLANTS DUE TO A NICKEL ALLERGY. ON (B)(6)2022, THE PATIENT UNDERWENT SURGERY AND HAD AN AR-8835-12 LOW PROFILE SCREW, TWO AR-8835-14 LOW PROFILE SCREWS, AN AR-8835-16 LOW PROFILE SCREW, AN AR-8835CL-10 KREULOCK COMPRESSION SCREW, TWO AR-8835CL-16 KREULOCK COMPRESSION SCREWS, TWO AR-8840C-45 LOW PROFILE SCREWS, AND AN AR-8943T-08 LOCKING THIRD TUBULAR PLATE IMPLANTED, ALL OF WHICH ARE COMPOSED OF STAINLESS STEEL. THERE WERE NO REPORTS OF ANY ISSUES DURING THE SURGERY. THREE MONTHS LATER, THE PATIENT STARTED TO EXPERIENCE HEALING PROBLEMS, SWELLING, A CHANGE IN THE KNEE COLOR, AND THE ANKLE BECOMING HOT TO THE TOUCH. THE PATIENT WAS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME STAGE ONE. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6)2022 BY THE SAME SURGEON TO HAVE ALL THE PREVIOUSLY IMPLANTED SCREWS AND PLATE REMOVED; NO NEW ARTHREX PRODUCTS WERE IMPLANTED. AFTER THE SURGERY, THE PATIENT WAS GIVEN A BOOT. DUE TO THE ALLERGIC REACTION TO THE IMPLANTS, THE PATIENT DEVELOPED DECREASED MOBILITY A

  Patient problems: Foreign Body Reaction

  MAUDE report 21322641 ↗
• InjurySep 27, 2023Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL CONCERNING 2 PIECES OF AR-8840C-45, LOW PROFILE SCREW¿, SS, 4.0 X 45 MM, CANNULATED, SHORT THREAD. FOR 1 OF THE AR-8840C-45, ITS SCREW HEAD WAS STRIPPED. BOTH WERE EVENTUALLY REMOVED FROM THE PATIENT DUE TO REDUCTION LOSS. THIS OCCURRED DURING A LEFT OPEN REDUCTION INTERNAL FIXATION ANKLE FRACTURE PROCEDURE ON (B)(6) 2023. AS PART OF A LEFT ANKLE ORIF (ALSO INCLUDING PLATE AND SYNDESMOSIS TIGHTROPES), SURGEON ATTEMPTED TO INSERT 2X 4.0MMX 45MM SHORT-THREAD CANNULATED SCREWS AR-8840C-45 INTO THE MEDIAL SIDE OF THE ANKLE. PER TECHNIQUE, THE SURGEON FIRST USED 1.35MM GUIDE WIRE AR-8943-01, GUIDE WIRE, TROCAR TIP, 1.35 MM X 130 MM, THEN OVERDRILLED WITH A AR-8943-02, DRILL BIT, CANNULATED, 2.6 MM. WHEN INSERTING THE SCREW USING THE AR-8943-12, DRIVE SHAFT, CANNULATED, QC, T15 HEXALOBE PER SURGICAL TECHNIQUE, THE SURGEON STATED THAT SHE WAS UNABLE TO ADVANCE THE SCREW PROPERLY AS THE DRIVER SHAFT WAS NOT ENGAGING PROPERLY WITH THE SCREW. FOR THE SECOND IDENTICAL SCREW, THE SURGEON SWITCHED TO THE AR-8943-09, SCREWDRIVER, T15 HEXALOBE, CANNULATED AND THE SURGEON STATED THAT THIS SCREW ADVANCED MORE SUCCESSFULLY. UPON IMAGING, THE S

  Patient problems: Insufficient Information

  MAUDE report 17824951 ↗