Arthrex® AR-8827L-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867047044), received between Mar 13, 2019 and Jan 27, 2020 — classified as 2 injuries.

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

• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN ORIGINAL ANKLE PROCEDURE (B)(6) 2017. DURING THE SURGERY SIX ARTHREX PRODUCTS WERE IMPLANTED. THE PATIENT DEVELOPED ALLERGIC LIKE REACTION SYMPTOMS AND RECENTLY HAD TO UNDERGO A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT THE ARTHREX DEVICES. PATIENT DID NOT HAVE AN FURTHER DETAILS AT THE TIME OF REPORT BUT WILL PROVIDE SOON. ADDITIONAL INFORMATION 1/8/2020: ORIGINAL PROCEDURE WAS ON (B)(6) 2017 AND WAS A LEFT ANKLE ORIF. FOLLOWING SURGERY THE PATIENT WAS IN THE HOSPITAL FOR THREE NIGHTS. SHE STARTED HAVING RINGING IN HER EARS AND DIZZINESS 3 MONTHS AFTER SURGERY. THIS WAS FOLLOWED BY TIREDNESS, MIGRAINES, AND TMJ ON HER RIGHT SIDE. SHE ALSO DEVELOPED NOTICEABLY DRIER, FLAKY SKIN AND MORE ANXIETY AFTER ABOUT 6 MONTHS. SHE DEVELOPED FOOD INTOLERANCE TO DAIRY AND DEVELOPED A THYROID NODULE AS WELL. PATIENT HAD A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT ALL OF THE ORIGINAL IMPLANT DEVICES. THE SECOND SURGERY WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE FOLLOWING DEVICES WERE REPORTED TO HAVE BEEN IMPLANTED (B)(6) 2017 AND EXPLANTED (B)(6) 2019 (SPECIFIC ARTHREX PART NUMBERS WERE NOT PROVIDED): AR-8926SS, KNOTLESS TIGHTRO

  Patient problems: Anxiety; Dizziness; Fatigue; Headache; No Code Available; Reaction; Tinnitus

  MAUDE report 9631387 ↗
• 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 MONTH 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 1

  Patient problems: Reaction; Skin Discoloration; Swelling

  MAUDE report 8417400 ↗