Arthrex® AR-8935-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867050525), received between Apr 18, 2019 and Aug 17, 2023 — 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.

• InjuryAug 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018 FOR AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT TRIMALLEOLAR ANKLE FRACTURE WITH FIXATION OF THE DISTAL FIBULA FRACTURE, POSTERIOR MALLEOLUS FRACTURE, AND SYNDESMOTIC FIXATION. DURING THE (B)(6) 2018 SURGERY, THE FOLLOWING PRODUCTS WERE USED AND/OR IMPLANTED: AR-8740-52PTS QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 52MM, LOT/SERIAL (B)(6), AR-8925T K-LESS T-ROPE W/DRV, SYN REPR, TI, LOT/SERIAL (B)(6), AR-8933-20 LO-PRO SCRW,TI,3.0MMX 20MMCORT, LOT/SERIAL (B)(6), AR-8933V-12 3.0 X 12MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-14 3.0 X 14MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-16 3.0 X 16MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-18 3.0 X 18MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8933V-20 3.0 X 20MM VAL SCREW, TI, LOT/SERIAL (B)(6), AR-8935-12 LO-PRO SCRW,TI,3.5MMX 12MM, LOT/SERIAL (B)(6), AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6), AR-8935-14 LO-PRO SCRW,TI,3.5MMX 14MM, LOT/SERIAL (B)(6), AR-8935-26 LO-PRO SCRW,TI,3.5MMX 26MM, LOT/SERIAL (B)(6), AR-8943-01 GUIDE WIRE, TROCAR TIP, 1.35 MM, LOT/SERIAL (B)(6), AR-8943-02 DRILL BIT, CANNULATED, 2.6MM, LOT/SERIAL (B)(6), AR-8943-16 2.0MM DRILL BIT, CALIBR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17563214 ↗
• 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 (QTY 2), 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: Distress; Itching Sensation; Reaction; Sleep Dysfunction

  MAUDE report 8526652 ↗