Arthrex® AR-8943T-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867052772), received between Aug 21, 2019 and Feb 6, 2025 — classified as 2 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 2 most recent of 2 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 MOBILITY

  Patient problems: Foreign Body Reaction

  MAUDE report 21322644 ↗
• InjuryAug 21, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A PATIENT'S RELATIVE HAS REPORTED THAT THE PATIENT HAD AN ANKLE ALLOGRAFT PROCEDURE IN (B)(6) 2018. DURING THE SURGERY AN ARTHREX PLATE AND SCREWS WERE IMPLANTED. SINCE THAT SURGERY THE PATIENT DEVELOPED MULTIPLE SYMPTOMS WHICH ARE BELIEVED TO BE AUTO-IMMUNE RELATED. THE PATIENT HAS TESTED POSITIVE FOR HAVING A NICKEL ALLERGY. PATIENT'S RELATIVE REPORTS THAT IT HAS BEEN SUGGESTED THAT IF PATIENT'S IMPLANTS CONTAIN NICKEL THIS COULD POSSIBLY BE THE CAUSE OF HER SYMPTOMS. SURGEON HAS TOLD THEM THE IMPLANTS RECEIVED DURING THE 2018 SURGERY WERE TITANIUM. REPORTER WAS REQUESTING THE MATERIAL COMPOSITION OF THE IMPLANT DEVICES TO DETERMINE IF THERE MAY POSSIBLY BE SOME NICKEL WITHIN THE COMPOSITION THAT COULD BE CAUSING THE PATIENT'S ISSUES. IN ADDITION TO THE AUTO-IMMUNE LIKE SYMPTOMS THE PATIENT'S RELATIVE STATES THAT THE PATIENT'S ANKLE REPAIR SURGERY WILL NEED TO BE REVISED BECAUSE THE REPAIR DID NOT WORK AND SHE IS UNABLE TO WALK OR PUT PRESSURE ON THAT ANKLE. SPECIFIC ARTHREX PART NUMBERS INVOLVED WERE UNKNOWN AT TIME OF INITIAL REPORT. REPORTER WILL OBTAIN AND PROVIDE. ADDITIONAL INFORMATION OBTAINED 7/31/2019: SALES REP HAS OBTAINED AND PROVIDED THE PATIENT IMPLANT PART NUMBERS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8916056 ↗