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Arthrex® AR-1927PBSRecalls & reported problems

Arthrex, Inc. · PUNCH,DISP CRKSCRW SWVLK ANCHS · Class 1

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867023567), received between Dec 13, 2021 and Dec 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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

  • Difficult to Remove1
  • Loose or Intermittent Connection1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 13, 2021Loose or Intermittent Connection; Difficult to Remove

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE DEVICE WAS INSERTED AND COULD NOT BE REMOVED BECAUSE THE BLUE HANDLE LOOSENED. THE BLUE HANDLE HAS ROTATED ACCORDINGLY AND COULD ONLY BE REMOVED WITH A PAIR OF PLIERS AND A HAMMER. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12983632 ↗

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Sources and updates

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