Arthrex® AR-7000-36FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867041080), received between Jul 19, 2017 and Sep 22, 2026 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858542 ↗
• MalfunctionNov 30, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-7000-36FT SCREW BROKE OFF DURING A SHOULDER REPAIR WHILE IT WAS BEING IMPLANTING. ALL WAS RETRIEVED. IT WAS REPLACED WITH ANOTHER SCREW FROM THE SAME PART / LOT AND THAT WORKED FINE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896572 ↗
• InjuryFeb 5, 2018Device Operates Differently Than Expected

  ALLEGED FAILURE OF AN ARTHREX PRODUCT WAS REPORTED BY THE PATIENT'S ATTORNEY VIA A PERSON INJURY COMPLAINT. NO FURTHER INFORMATION IS AVAILABLE AT TIME OF INITIAL REPORT. ADDITIONAL INFORMATION OBTAINED 1/11/2018: OP REPORT (B)(6) 2014 RECORDS NOTED THAT THE PATIENT HAS A HISTORY OF DISLOCATIONS OF HIS SHOULDER WHICH WAS PREVIOUSLY TREATED WITH AN ARTHROSCOPIC CAPSULORRHAPHY. PATIENT HAD ONGOING EVIDENCE OF INSTABILITY OF THE SHOULDER. ON (B)(6) 2014 A RIGHT OPEN LATARJET RECONSTRUCTION PROCEDURE WAS PERFORMED ON PATIENT'S RIGHT SHOULDER USING A CONGRUENT ARC TECHNIQUE. MEDICAL RECORDS DATED (B)(6) 2015 NOTE THAT DURING THE POST-OPERATIVE PERIOD, THERE WAS A FAILURE OF THE HARDWARE AND A NON-UNION OF THE CONGRUENT ARC RECONSTRUCTION. RECORDS NOTE THE PATIENT MAY HAVE EXPERIENCED A SEIZURE WHEN THE FAILURE OF THE HARDWARE OCCURRED. A REVISION CONGRUENT ARC RECONSTRUCTION WITH A POSSIBLE ILIAC CREST BONE GRAFT WAS PERFORMED ON (B)(6) 2015. THE ORIGINAL SURGEON ALSO PERFORMED THE REVISION PROCEDURE. THE SURGEON IDENTIFIED THE REMNANT OF THE CORACOID PROCESS, WHICH WAS USED IN THE ANTERIOR ARC RECONSTRUCTION. IT WAS NOTED TO BE SMALL AND IT HAD A FRACTURE THROUGH THE SUPERIOR SCREW HOL

  Patient problems: Bone Fracture(s); Joint Dislocation; Seizures

  MAUDE report 7241450 ↗
• InjuryJul 19, 2017Overheating of Device; Material Torqued

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY PROCEDURE, WHERE A 3.75MM CANNULATED FULLY THREADED SCREW WAS IMPLANTED INTO THE RIGHT SHOULDER. ON (B)(6) 2017, THE PATIENT WAS SEEN AT EAST BAPTIST OUTPATIENT WHERE HE UNDERWENT AN MRI ON HIS RIGHT KNEE. AFTER THE SECOND 15-SECOND SCAN, THE PATIENT BEGAN TO EXPERIENCE THE SCREW IN HIS SHOULDER HEAT UP AND STATED THAT HE FELT LIKE IT HAD "TORQUED". THERE WAS NO MOVEMENT IN THE PATIENT'S SHOULDER AND THE PATIENT WILL BE FOLLOWING UP WITH HIS SURGEON. PATIENT IS A (B)(6) MALE.

  Patient problems: No Information

  MAUDE report 6724257 ↗