Arthrex® AR-8840-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867047761), received between Feb 21, 2018 and Apr 18, 2025 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionApr 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT REPORTED VIA PHONE A DISLOCATION THAT REQUIRED METAL PARTS TO STABILIZE THE TIBIA. ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN RIGHT ANKLE FRACTURE PROCEDURE DURING WHICH AN AR-8943C-10 LOCKING STRAIGHT PLATE, (QTY. 4) OF AN AR-8835-14 LOW PROFILE NONLOCKING SCREW, SS, 3.5 X 14 MM, AN AR-8835-16 LOW PROFILE SCREW, SS, 3.5 X 16 MM, CORTICAL, AN AR-8840-14 LOW PROFILE SCREW, SS, 4.0 X 14 MM, CANCELLOUS, AN AR-8840-12 LOW PROFILE SCREW, SS, 4.0 X 12 MM, CANCELLOUS, (QTY. 2) OF AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL, AND AN (QTY 2) OF AN AR-1322BNF SUTURE ANCHOR, MINI BIO-SUTURETAK 2.4 X 8.5 MM WITH 2-0 FIBERWIRE WITH TWO TAPER POINT NEEDLES WERE IMPLANTED. THE PATIENT HAS REPORTED AN ALLERGIC REACTION AFFECTING THE ENTIRE LEG INTERNALLY AND EXTERNALLY, CAUSING SIGNIFICANT SWELLING AND INTENSE PAIN. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 4/15/2025: THE PATIENT IS UNABLE TO CONFIRM WHETHER THE REACTION IS ALLERGY-RELATED UNTIL THE METAL IS REMOVED, WHICH IS SCHEDULED WITHIN THE NEXT TWO WEEKS. THE PATIENT HAS A DOCUMENTED HISTORY OF SURGICAL STAINLESS-STEEL ALLERGY AND A CONFIRMED NICKEL ALLERGY. NO FURTHER INFORMATION HAS BEEN REPOR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21865606 ↗
• InjuryJun 2, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD A PRIMARY ORIF ANKLE FX PERFORMED ON (B)(6) 2019, AND WAS WALKING AT 10 WEEKS. WITHOUT EXPERIENCING A NEW INJURY, THE IMPLANTED ARTHREX PLATE BROKE AND DISPLACED THE FX. THE PATIENT WILL NEED A SECOND SURGERY. THERE WAS NOT AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE INITIAL CASE. 10 WEEK X-RAYS REVEALING THE BROKEN PLATE HAVE BEEN PROVIDED TO ARTHREX. ADDITIONAL INFORMATION RECEIVED ON 03/20/2020: THE REP PROVIDED THE ORIGINAL SALES ORDER FROM THE PRIMARY PROCEDURE. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE PRIMARY SURGERY; AR-8943T-10 // LOT: 474735 X 1, AR-8835-14 // LOT: 10266334 X 1, AR-8835-14 // LOT: 10268858 X 1, AR-8835-14 // LOT: 10273289 X 1, AR-8835-14 // LOT: 10291574 X 1, AR-8835-16 // LOT: 10221152 X 1, AR-8835-18 // LOT: 10211116 X 1, AR-8835-18 // LOT: 10223067 X 1, AR-8840-14 // LOT: 10035722 X 1, AT TIME OF INITIAL REPORT TO ARTHREX (MARCH 9-2020) OR WHEN THE ADDITIONAL INFORMATION WAS PROVIDED, ON MARCH 20-2020, THE SALES REP DID NOT HAVE ANY ADDITIONAL DETAILS PERTAINING TO THE EXPECTED SECOND SURGERY. ADDITIONAL INFORMATION OBTAINED 5/13/20: THERE WAS A DELAY IN OBTAINING INFORMATION DUE TO THE COVID-19 P

  Patient problems: No Code Available

  MAUDE report 10108734 ↗
• InjuryFeb 21, 2018Insufficient Device Problem Information

  IT WAS REPORTED BY A DERMATOLOGIST'S OFFICE THAT A PATIENT IS CONCERNED HE IS ALLERGIC TO A COMPONENT OF THE PLATE AND SCREWS USED TO FIX HIS ANKLE IN 2015 AFTER HE SUFFERED A BREAK. REPORTER HAS REQUESTED MATERIAL COMPOSITION OF THE DEVICES. THE FOLLOWING ARE THE IMPLANTED DEVICES: AR-8943TH-05, LOCKING LATERAL HOOK PLATE, STAINLESS STEEL ((B)(4)). AR-8835-30, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-18, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8835-14, LOW PROFILE CORTICAL SCREW, STAINLESS STEEL ((B)(4)). AR-8840-14, LOW PROFILE CANCELLOUS SCREW, STAINLESS STEEL ((B)(4)). AR-8926SS, KNOTLESS TIGHTROPE SYNDESMOSIS REPAIR IMPLANT. FOLLOW-UP INVESTIGATION: PATIENT'S ORIGINAL SURGERY WAS IN (B)(6) 2014 (NOT 2015 AS ORIGINALLY REPORTED). SPECIFIC DATE IS UNKNOWN. SURGERY WAS AN ORIF OF THE LEFT ANKLE. PATIENT IS A MALE WITH KNOWN ALLERGY TO AMOXICILLIN. PATIENT HAS BEEN EXPERIENCING CHRONIC FATIGUE AND SLEEPINESS, ANXIETY AND PALPITATIONS AND BRADYCARDIA. TREATMENTS TO DATE ARE UNKNOWN. MATERIAL COMPOSITION OF THE IMPLANTED DEVICES HAS BEEN PROVIDED THE REPORTER. DEVICES ARE STAINLESS STEEL. SINCE A SPECIFIC DAY FOR THE ORIGINAL (B)(6) 2014 SURGERY

  Patient problems: Anxiety; Bradycardia; Fatigue; Palpitations; Sleep Dysfunction

  MAUDE report 7285141 ↗