Arthrex® AR-8740-50HRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867127937), received between Feb 9, 2021 and Apr 15, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 3/20/2024, AN INQUIRY WAS SUBMITTED BY A NURSE CASE MANAGER VIA PHONE FOR A PATCH TEST KIT ON BEHALF OF A PATIENT AND SURGEON. THE PATIENT IS EXPERIENCING SEVERE ITCHING ON BOTH ANKLES AND FEMUR WHERE THE AR-8740-40H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 40 MM, AR-8740-48H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 48 MM, AND AR-8740-50H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 50 MM WAS IMPLANTED. THEY WOULD LIKE TO KNOW IF THESE SCREWS ARE THE CAUSE OF THE SENSITIVITY THE PATIENT IS EXPERIENCING. IF PROVEN, THERE WILL BE AN ADDITIONAL SURGERY TO REMOVE THE SCREWS. ADDITIONAL INFORMATION WAS RECEIVED ON 3/22/2024: MATERIAL COMPOSITION WAS REQUESTED BY THE NURSE CASE MANAGER ON AR-8740-40H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 40 MM, AR-8740-48H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 48 MM, AND AR-8740-50H STANDARD COMPRESSION FT, TITANIUM, 4 MM X 50 MM THAT WAS IMPLANTED IN THE PATIENT DURING A ORIF OF LEFT AND RIGHT TALUS AS WELL AS ARTHROSCOPY WITH FOREIGN BODY REMOVAL OF LEFT AND RIGHT ANKLE ON (B)(6) 2021. S CREWS WERE USED BILATERALLY. THE SYMPTOMS OF SEVERE ITCHING AND SKIN IRRITATION HAVE BEEN OCCURRING SINCE SHORTLY AFTER THIS TIME AND THE PATIENT HAS BEEN TR

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19107099 ↗
• MalfunctionOct 24, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 10/17/2023: THE CASE WAS COMPLETED USING ANOTHER AR-8740-50H STANDARD COMPRESSION FT. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS UNNECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994833 ↗
• InjuryNov 8, 2021Break

  ON 10/19/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8740-50H SCREW BROKE DURING INSERTION OF THE MEDIAL MALLEOLUS. THIS OCCURRED DURING A ARTHROSCOPIC MEDIAL MALLEOLUS ORIF ON (B)(6) 2021 PROPER PREPARATION OF THE BONE SOCKET WAS DONE AS OBSERVED, THE FIRST HALF WAS INSERTED WITH POWER SUBSEQUENTLY THEN SWITCHED TO HAND, THE SCREW BROKE AFTER A FEW TURNS BY HAND. THE BROKEN POINT WAS AT THE CONJUNCTION OF THE CORTICAL AND CANCELLOUS THREAD. THE SCREW WAS REMOVED USING PLIERS, AND THE INCISION WAS EXTENDED IN ORDER TO ACCESS THE BROKEN PART OF THE SCREW. A DOWNSIZED SCREW WAS USED AFTER TO COMPLETE THE CASE. THE SURGERY WAS DELAYED TO THIS INCIDENT. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 10/20/2021 THERE¿S NO LOT NUMBER ON THE SCREW AS IT WASN¿T A SINGLE PACKED PRODUCT. THUS I COULDN¿T PROVIDE THE LOT NUMBER. A 1.1MM GUIDEWIRE AND 3.2MM CANNULATED DRILL BIT WAS USED TO PREPARE BONE SOCKET. BONE SHOULD BE HARD AS PATIENT IS YOUNG. OPERATION WAS DELAYED FOR ABOUT 30MINS. ADDITIONAL ANAESTHETIC WAS REQUIRED. A 4X40MM SCREW WAS USED TO COMPLETE THE OPERATION AFTER THE BROKEN SCREW BEEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770320 ↗
• MalfunctionFeb 9, 2021Break

  IT WAS REPORTED THAT DURING A MEDIAL MALLEOLUS OSTEOTOMY AND FIXATION PROCEDURE, THE COMPRESSION FT SCREW, AR-8740-50H, BROKE WHILE BEING INSERTED INTO THE HOLE DRILLED USING A PROFILE DRILL AND LONG DRILL. THE BROKEN PART WAS AT THE CONJUNCTION OF THE CORTICAL AND CANCELLOUS THREAD. THE SCREW BROKE WHEN ONLY 1CM WAS INSERTED. THE BROKEN FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED WITH AN AR-8740-48H WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 11301226 ↗