Arthrex® AR-7000-34FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867041059), received between Mar 12, 2018 and Mar 12, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2018Appropriate Device Problem Term/Code Not Available

  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 4-17-15 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 HOLE. T

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 7330180 ↗