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Arthrex® AR-1927BNFRecalls & reported problems

Arthrex, Inc. · SUTR ANCH,BIOCRKSCRW,FT, VENT · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00888867023505), received between Aug 23, 2016 and Aug 23, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

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

  • InjuryAug 23, 2016Break

    IT WAS REPORTED VIA A MEDWATCH LETTER (MW5063409) THAT THE FOLLOWING WAS REPORTED: A PATIENT UNDERWENT A REPAIR OF A SHOULDER ROTATOR CUFF TEAR AND WHILE THE SURGEON WAS SCREWING THE SUTURE ANCHOR IN PLACE, THE IMPLANT BROKE. APPROXIMATELY HALF OF THE IMPLANT REMAINED IN THE PATIENT SHOULDER. PER THE MEDWATCH REPORT THE SURGEON DETERMINED THAT FIXATION OF THE IMPLANT WAS OKAY AND REMOVAL WAS UNNECESSARY. THE MEDWATCH DID NOT INCLUDE FACILITY NAME, ADDRESS OR CONTACT INFORMATION. THEREFORE, NO ADDITIONAL INFORMATION COULD BE OBTAINED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 5895822 ↗

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Sources and updates

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