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Arthrex® AR-2264Recalls & reported problems

Arthrex, Inc. · AC TIGHTROPE, TWIN TAIL · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867026513), received between May 20, 2020 and May 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Fall1
  • Injury1
  • Pain1

Recent adverse event reports

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

  • InjuryMay 20, 2020Device Dislodged or Dislocated

    IT WAS REPORTED THAT ABOUT THREE MONTHS AGO, THE PATIENT SUFFERED AN ACCIDENTAL FALL AND INJURED HIS LEFT SHOULDER. AN X-RAY SHOWED A DISLOCATION OF THE LEFT ACROMIOCLAVICULAR JOINT. THE PATIENT UNDERWENT A SURGERY FOR DISLOCATION OF THE LEFT ACROMIOCLAVICULAR JOINT WHERE A TWIN TAIL AC TIGHTROPE, AR-2264, WAS IMPLANTED. THE SHOULDER OF THE PATIENT GRADUALLY RECOVERED TO NORMAL MOVEMENT FUNCTION, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ONE MONTH AFTER DISCHARGE, THE PATIENT FOLLOWED UP FOR REEXAMINATION AND AN X-RAY SHOWED THAT THE BUTTON THAT WAS IMPLANTED WITH THE TWIN TAIL AC TIGHTROPE, AR-2264, UNDER THE CORACOID OF THE LEFT SHOULDER, HAD SHIFTED AND THE ACROMIOCLAVICULAR JOINT WAS DISLOCATED ONCE AGAIN. THE PATIENT HAD NO PAIN IN THE LEFT SHOULDER AND WAS ABLE TO DO NORMAL MOVEMENT. FOLLOW-UP OBSERVATION WAS CONDUCTED ONE MONTH AGO AND THE PATIENT FELT PAIN WHEN THE LEFT SHOULDER WAS PERFORMING NORMAL MOVEMENT; WHICH AFFECTED THE MOVEMENT AND MADE NO IMPROVEMENT AFTER REST. ON (B)(6), THE PATIENT WAS SEEN AGAIN FOR RE-EXAMINATION, AND THE X-RAY SHOWED: "THE BUTTON UNDER THE CORACOID OF THE LEFT SHOULDER SHIFTED, AND THE ACROMIOCLAVICULAR JOINT WAS COMPLETELY DISLOCAT

    Patient problems: Fall; Injury; Pain

    MAUDE report 10074702 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.