Arthrex® AR-8935-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867050501), received between Oct 19, 2016 and Aug 13, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Break

  ON 07/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8935-24 SCREW BROKE WHILE GOING INTO A AR-7654EL-11S. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED BY LEAVING THE BROKEN HARDWARE IN AND USING OTHER SCREW HOLES. NO DELAY TO THE CASE

  Patient problems: Foreign Body In Patient

  MAUDE report 22795135 ↗
• InjuryMar 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2023. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW WERE IMPLANTED. DUE TO NONUNION, THE PATIENT UNDERWENT A SECOND SURGERY ON (B)(6) 2024 TO HAVE AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCREW, TWO AR-18827V-20 VAL SCREW AN AR-18827V-10 VAL SCREW, AND AN ABS-2010-10 ALLOSYNC PURE IMPLANTED. ALL THE PREVIOUSLY IMPLANTED PRODUCTS DURING THE INITIAL SURGERY ON (B)(6) 2023 REMAINED IN THE PATIENT.

  Patient problems: Malunion of Bone

  MAUDE report 21536458 ↗
• InjuryMar 3, 2025Break; Break

  ON 12/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ALPHA PLATE BROKE POSTOPERATIVELY. THE PATIENT WAS PICKING UP THE CAT AND FELT A BREAK. X-RAYS CONFIRM THE PLATE BROKE THROUGH THE OBLONG HOLE IN THE FIRST BEND OF THE PLATE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 2/6/2025: ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE LEFT ALPHA PLATE BREAKING AND CAUSING THE REINFORCED STRAIGHT PLATE TO DISLODGE. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW, AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCRE

  Patient problems: Foreign Body In Patient

  MAUDE report 21503558 ↗
• 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

  MAUDE report 8526653 ↗
• InjurySep 10, 2018Patient-Device Incompatibility

  A PATIENT REPORTED THAT SHE UNDERWENT A PLANTAR LAPIDUS PROCEDURE ON HER RIGHT FOOT ON (B)(6) 2018. SINCE HER SURGERY PATIENT HAS BEEN EXPERIENCING WHAT SHE FEELS MAY BE POSSIBLE REACTION SYMPTOMS IN AND AROUND THE SURGICAL SITE WHICH INCLUDE: SLOW WOUND HEALING, REDNESS, ROUGH SKIN, SWELLING AND INFLAMMATION WHICH FLARES UP WORSE AT TIMES. PATIENT STATED THAT THERE IS NO INFECTION. PATIENT HAS PLANS TO GO TO AN ALLERGIST FOR ALLERGY TESTING TO THE MATERIALS WHICH COMPRISE HER ARTHREX IMPLANTS. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE (B)(6) 2018 SURGERY: AR-8941PR PLATE (QTY 1), AR-8935-24 CORTICAL SCREW (QTY 1), AR-8935-22 CORTICAL SCREW (QTY 1), AR-8935-28 CORTICAL SCREW (QTY 1) AND AR-8935-18 CORTICAL SCREW (QTY 2). DEVICES ARE TITANIUM AND PATIENT HAS BEEN PROVIDED THE MATERIAL COMPOSITION BREAKDOWN OF THE ASTM TITANIUM STANDARDS OF THE DEVICE MATERIAL.

  Patient problems: Erythema; Impaired Healing; Inflammation; Swelling

  MAUDE report 7861367 ↗
• InjuryOct 19, 2016Device Dislodged or Dislocated

  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 (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 09/27/16: REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2016 TO REMOVE THE AR-8942R-M, H-PLATE ((B)(4) (B)(6)), AND THE SCREWS, AR-8935-24, LO-PRO SCREW, QTY 1 ((B)(4) (B)(6)), AR-8935L-26, LOCKING SCREW, QTY 1 ((B)(4) (B)(6)) AND AR-8935L-30, LOCKING SCREW, QTY 2 ((B)(4) (B)(6)).

  Patient problems: No Code Available

  MAUDE report 6039358 ↗