Arthrex® AR-8935-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867050624), received between Apr 18, 2019 and Mar 9, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryMar 9, 2020Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD ANKLE RECONSTRUCTION SURGERY A FEW YEARS AGO UTILIZING ARTHREX PRODUCTS. SINCE SURGERY SHE HAS DEVELOPED REACTION TYPE SYMPTOMS WHICH INCLUDE RASHES AT THE SURGICAL SITE. PATIENT IS SEEKING MATERIAL COMPOSITION OF THE DEVICES. PATIENT WILL PROVIDE ADDITIONAL INFORMATION VIA EMAIL AND WILL OBTAIN THE SPECIFIC PART NUMBERS INVOLVED TO PROVIDE TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 02/17/2020: PATIENT'S SURGERY TOOK PLACE (B)(6) 2013. PROCEDURE WAS ON HER RIGHT FOOT. SHE HAD AN ACCESSORY NAVICULAR REMOVED AND THE ARCH IN HER FOOT WAS CORRECTED. PATIENT REPORTS HER ANKLE HAS ALWAYS BEEN TENDER BUT SHE FIGURED THAT WAS NORMAL (LONG LASTING EFFECTS OF SURGERY). SHE BEGAN HAVING RASHES ON HER KNUCKLES AROUND THE END OF 2016. IN THE PAST YEAR SHE HAS HAD RASHES ON HER SHINS; WHAT LOOKS LIKE POLPHOLYX ON HER FINGERS THAT COMES AND GOES; AND A SMALL PATCH OF DRY/CRUSTY SKIN ON HER OUTER RIGHT ANKLE. THE ONLY THING THAT SEEMS TO HELP THE PATIENT IS ORAL BENADRYL. IN (B)(6) 2018 PATIENT'S EYESIGHT SUDDENLY BECAME SENSITIZED TO HIGH CONTRACT IMAGES/ LIGHTING. PATIENT HAS HEADACHES MORE OFTEN THAN EVER BEFORE. PATIENT'S OPHTHALMOLOGIST SAYS THE ST

  Patient problems: Increased Sensitivity; Rash; Reaction; Visual Impairment

  MAUDE report 9805070 ↗
• InjuryApr 18, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY A PATIENT, THROUGH THE ARTHREX WEBSITE, THAT SHE HAD UNDERGONE A CALCANEUS REPAIR PROCEDURE (B)(6) 2017. LESS THAN TWO WEEKS POST SURGERY PATIENT'S BACK STARTED ITCHING AND THIS HAS SINCE SPREAD ALL OVER HER BODY AND PATIENT REPORTS THIS IS CAUSING HER GREAT STRESS AND LACK OF SLEEP. AT THE TIME OF INITIAL REPORT THE PATIENT DID NOT HAVE THE ARTHREX PRODUCT NUMBERS FOR HER IMPLANTS. PATIENT HAS REQUESTED AND WILL BE PROVIDED WITH THE MATERIAL COMPOSITION OF HER IMPLANTS ONCE THE PART NUMBERS ARE PROVIDED TO ARTHREX. ADDITIONAL INFORMATION OBTAINED 4/3/2019: PATIENT HAS PROVIDED THE IMPLANT LOG FROM HER SURGERY. THE FOLLOWING ARE THE PATIENT'S ARTHREX IMPLANT PART NUMBERS. LOT NUMBERS WERE NOT PROVIDED ON THE IMPLANT LOG AND ARE NOT AVAILABLE: CALCANEUS PLATE: AR-8954PR-XS (QTY 1); 3.5MM LOCKING SCREWS: AR-8935L-28 (QTY2), AR-8935L-22 (QTY 1); 3.5MM NON-LOCKING SCREWS:(QTY 1 EACH) AR-8935-38, AR-8935-36, AR-8935-34, AR-8935-30, AR-8935-26, AR-8935-24. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES IS BEING PROVIDED TO THE PATIENT.

  Patient problems: Itching Sensation; Sleep Dysfunction

  MAUDE report 8526647 ↗