Arthrex® AR-8835-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867047273), received between Jun 21, 2018 and Feb 6, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• 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 21322629 ↗
• 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: Ambulation or Postural Difficulties; Autoimmune Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 8916089 ↗
• InjuryMar 13, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE ANKLE SURGERY ON (B)(6) 2013 DURING WHICH TIME ARTHREX DEVICES WERE IMPLANTED. PATIENT MAY POSSIBLY BE HAVING AN ALLERGIC REACTION TO THE IMPLANT MATERIALS AND WAS INQUIRING ABOUT THE MATERIAL COMPOSITION. AT TIME OF INITIAL REPORT PATIENT DID NOT HAVE THE SPECIFIC PRODUCT NUMBERS OF HER IMPLANTS. PATIENT DOES NOT HAVE AN ALLERGY TO METAL BUT DOES HAVE ALLERGIES TO AT LEAST ONE COMPONENT OF TITANIUM, WHICH IS VANADIUM. ADDITIONAL INFORMATION OBTAINED 2/18/19: THE PROCEDURE ON (B)(6) 2013 WAS TO REPAIR AND ANKLE FRACTURE. THE PATIENT'S SYMPTOMS BEGAN SEVERAL MONTHS AFTER SURGERY. THE AREA AROUND THE SURGICAL SITE BECAME SWOLLEN WITH SKIN DISCOLORATIONS AS WELL AS TEXTURE WHICH CONTINUE SEVERAL YEARS POST OP. PATIENT HAS FREQUENT FEELINGS OF STIFFNESS AND PRESSURE IN THE AREA AS WELL. PATIENT HAS BEEN TREATED WITH MOBIC (NON-STEROIDAL ANTI-INFLAMMATORY DRUGS). MATERIAL COMPOSITION OF THE IMPLANTED DEVICES, WHICH ARE COMPRISED OF STAINLESS STEEL AND MEET ASTM STANDARDS, HAS BEEN PROVIDED TO THE PATIENT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2013 PROCEDURE: AR-8943BR-06, LOCKING DISTAL FIBULA PLATE, RIGHT 6 HOLE (QTY

  Patient problems: Hypersensitivity/Allergic reaction; Swelling

  MAUDE report 8417403 ↗
• InjuryJun 21, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A REVISION LT ANKLE FX PROCEDURE A TOTAL OF QTY. 3 AR-8827L-12 (LOT: 031731, LOT: 10158067, LOT: 185363) AND QTY. 2 AR-8827L-14 (LOT: 031725) WOULD NOT STAY ENGAGED IN THE PLATE. THE BONE WAS PREPPED BY A 2.0MM DRILL. ADDITIONAL INFORMATION RECEIVED 6/12/2018: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017. THE TYPE OF PROCEDURE BEING PERFORMED WAS A FIBULA FX. THE CASE TOOK PLACE AT (B)(6) HOSPITAL AND THE SURGERY WAS PERFORMED BY DR. (B)(6). THE FOLLOWING ARTHREX PART NUMBERS WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE (LOT NUMBERS OF THE DEVICES ARE UNKNOWN). AR-8943BL-05; AR-8835-12 (QTY. 2); AR-8830-14 (QTY. 1); AR-8835-14 (QTY. 1); AR-8827L-14 (QTY. 3); AR-8827L-10 (QTY. 1). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018 TO FIX A HIGH NON UNION FIBULA FX. IT IS UNKNOWN IF OR WHAT SPECIFIC PART AND LOT NUMBERS WERE EXPLANTED DURING THE (B)(6) 2018 REVISION SURGERY. DURING THE REVISION SURGERY, A 2.7 LOCKING GUIDE WAS PLACED INTO THE LOCKING HOLE. THE BONE WAS DRILLED WITH A 2MM DRILL. A QUANTITY OF 3 AR-8827L-12, LOW PROFILE LOCKING SCREW(S) (LOT: 031731/LOT: 10158067/LOT: 185363) WOULD NOT FULLY ENGAGE INTO THE FIBULA PLATE. THE SURGEON BACKED

  Patient problems: Failure of Implant

  MAUDE report 7625182 ↗