Arthrex® AR-8935L-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867050976), received between Oct 19, 2016 and Mar 9, 2020 — classified as 3 injuries.

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

• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem

  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 S

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 9805080 ↗
• InjurySep 5, 2018Break

  DURING REMOVAL OF SCREWS/HARDWARE POST LISFRANC HEALING - SCREWS WERE BROKEN. THE DEVICES INVOLVED WERE AS FOLLOWS: AR-8935L-26 QTY 1, AR-8935L-20 QTY2, AR-8935-18 QTY 1. ADDITIONAL INFORMATION OBTAINED 8/27/2018: THE ORIGINAL LISFRANC PROCEDURE TOOK PLACE ON (B)(6) 2017. IT WAS DISCOVERED THAT THE SCREWS WERE BROKEN AND THE REVISION WAS SCHEDULED DUE TO PATIENT PAIN AND BROKEN HARDWARE. THE DATE OF THE REVISION PROCEDURE WAS (B)(6) 2018, DURING WHICH BROKEN SCREWS WERE EXPLANTED. BOTH ORIGINAL AND REVISION PROCEDURES WERE PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON. IT IS UNKNOWN IF ALL ORIGINAL IMPLANTS WERE EXPLANTED DURING THE REVISION. RISK MANAGER COULD ONLY CONFIRM THAT THE REPORTED SCREWS WERE EXPLANTED.

  Patient problems: Pain

  MAUDE report 7846927 ↗
• InjuryOct 19, 2016Device Slipped

  IT WAS REPORTED VIA AN ARTHREX WEBSITE INQUIRY THAT A PATIENT WITH A SCREW AND PLATE IN HER ANKLE NEEDS TO HAVE IT REMOVED. SURGEON REPORTED TO SALES REP THAT A SCREW IS BACKING OUT. THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2014 ON THE RIGHT FOOT BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE DEVICES ARE REPORTED TO BE AN ARTHREX 6.5 MM CANNULATED SCREWS AND 4.5 CANNULATED SCREWS WITH AN H-PLATE AND LOCKING SCREWS. ADDITIONAL INFORMATION OBTAINED ON (B)(4) 2016: REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 TO REMOVE THE AR-8942R-M, H-PLATE ((B)(6)), AND THE SCREWS, AR-8935-24, LO-PRO SCREW, QTY 1 ((B)(6)), AR-8935L-26, LOCKING SCREW, QTY 1 ((B)(6)) AND AR-8935L-30, LOCKING SCREW, QTY 2 ((B)(6)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6039357 ↗