Arthrex® AR-8730-34HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867127067), received between Aug 23, 2016 and Sep 18, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2019Break

  IT WAS REPORTED THAT A 3.5X34MM HEADLESS FT SCREW WAS BEING USED DURING A NAVICULAR STRESS FRACTURE PROCEDURE. THE SURGEON WAS TRYING THE DRIVE THE SCREW FLUSH WHEN A PORTION SNAPPED AND PART OF THE SCREW CAME OUT WITH THE DRIVER. THE PORTION THAT WAS IN BONE WOULD HAVE NEEDED TO BE CORED OUT SO THE SURGEON OPTED TO LEAVE IT IN AS HE STILL GOT ADEQUATE COMPRESSION. ADDITIONAL INFORMATION PROVIDED 8/28/19: THE REMAINING FRAGMENT WAS LEFT IN BONE AS THEIR WAS NO EASY WAY TO REMOVE AND THE SURGEON WAS STILL CONFIDENT IN THE FIXATION AND COMPRESSION. ADDITIONAL INFORMATION PROVIDED 10/8/19: WHILE PREPPING THE BONE, JUST THE STRAIGHT DRILL WAS USED. NO PROFILE DRILL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9081014 ↗
• InjuryAug 21, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A PATIENT'S RELATIVE HAS REPORTED THAT THE PATIENT HAD AN ANKLE ALLOGRAFT PROCEDURE IN (B)(6) 2018. DURING THE SURGERY AN ARTHREX PLATE AND SCREWS WERE IMPLANTED. SINCE THAT SURGERY THE PATIENT DEVELOPED MULTIPLE SYMPTOMS WHICH ARE BELIEVED TO BE AUTO-IMMUNE RELATED. THE PATIENT HAS TESTED POSITIVE FOR HAVING A NICKEL ALLERGY. PATIENT'S RELATIVE REPORTS THAT IT HAS BEEN SUGGESTED THAT IF PATIENT'S IMPLANTS CONTAIN NICKEL THIS COULD POSSIBLY BE THE CAUSE OF HER SYMPTOMS. SURGEON HAS TOLD THEM THE IMPLANTS RECEIVED DURING THE 2018 SURGERY WERE TITANIUM. REPORTER WAS REQUESTING THE MATERIAL COMPOSITION OF THE IMPLANT DEVICES TO DETERMINE IF THERE MAY POSSIBLY BE SOME NICKEL WITHIN THE COMPOSITION THAT COULD BE CAUSING THE PATIENT'S ISSUES. IN ADDITION TO THE AUTO-IMMUNE LIKE SYMPTOMS THE PATIENT'S RELATIVE STATES THAT THE PATIENT'S ANKLE REPAIR SURGERY WILL NEED TO BE REVISED BECAUSE THE REPAIR DID NOT WORK AND SHE IS UNABLE TO WALK OR PUT PRESSURE ON THAT ANKLE. SPECIFIC ARTHREX PART NUMBERS INVOLVED WERE UNKNOWN AT TIME OF INITIAL REPORT. REPORTER WILL OBTAIN AND PROVIDE. ADDITIONAL INFORMATION OBTAINED 7/31/2019: SALES REP HAS OBTAINED AND PROVIDED THE PATIENT IMPLANT PART NUMBERS.

  Patient problems: Autoimmune Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 8916629 ↗
• InjuryMar 29, 2017Break

  IT WAS REPORTED THAT DURING AN ORIF LEFT FOOT NAVICULAR PROCEDURE, THE SURGEON WAS INSERTING AN AR-8730-34H, 3.5 MINI COMPRESSION FT SCREW 34 MM LENGTH. UPON INSERTION, THE LAST 8 MM OF THE SCREW BROKE. THE REMAINING 26 MM OF THE SCREW WAS LEFT IN THE NAVICULAR AS IT WAS ACROSS THE FRACTURE PLANE AND REPORTED TO BE SECURE. A SECOND MINI COMPRESSION SCREW OF THE SAME PART AND LOT NUMBER WAS OPENED AND USED TO COMPLETE THE CASE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6442782 ↗
• InjurySep 30, 2016Break

  IT WAS REPORTED THAT AT THE END OF THE IMPLANTATION, THE SCREW BROKE. A PART OF THE BROKEN SCREW REMAINED IN THE PATIENT'S BONE. IT WAS NOT REPORTED WHICH SCREW WAS SUCCESSFULLY USED TO FINISH THE SURGERY. THE SURGERY ENDED WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 5989907 ↗
• InjuryAug 23, 2016Break

  IT WAS REPORTED THAT DURING A METATARSAL PHALNGEAL FUSION (FIRST METATARSAL AND PROXIMAL PHLANX) THE AR-8730-34H COMPRESSION FT SCREW, .5 MINI, 34 MM LENGTH HAD BROKEN IN HALF. THIS ISSUE WAS DISCOVERED UPON RADIOGRAPHICAL EXAMINATION DURING THE PROCEDURE. THE BROKEN SCREW WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT THE MTP FUSION PLATE PROVIDED GREAT COMPRESSION DESPITE THE SCREW BREAKING. NO ADDITIONAL SCREW WAS NEEDED DUE TO THE SCREW BREAKAGE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADDITIONAL INCISIONS. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5896897 ↗