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Arthrex® AR-4154P-3010Recalls & reported problems

Arthrex, Inc. · 2.5 X 30MM PIP DART, PEEK, 10 DEGREE · 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 00888867102439), received between Jan 26, 2017 and Jan 26, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Fitting Problem1

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.

  • InjuryJan 26, 2017Break; Fitting Problem

    IT WAS REPORTED THAT THE SURGEON DRILLED A HOLE IN THE BONE WITH THE ASSOCIATED DRILL AND INSERTED THE ANCHOR. ANCHOR DID NOT FIT IN HOLE AND SURGEON PULLED THE ANCHOR BACK. ANCHOR BROKE AND A PIECE OF THE ANCHOR REMAINED IN PATIENT'S BONE. SURGEON REMOVED THE FRAGMENT BY EXPANDING THE HOLE WITH A DRILL. SURGERY WAS SUCCESSFULLY FINISHED USING THE REMAINING PART OF THE DART.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 6278838 ↗

Other PIN, FIXATION, SMOOTH devices

All PIN, FIXATION, SMOOTH devices →

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