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Arthrex® AR-1407LPRecalls & reported problems

Arthrex, Inc. · REAMER, LOW PROFILE · Class 1

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

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867016682), received between Nov 13, 2018 and Sep 14, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2
  • Entrapment of Device1

Patient problems

  • Device Embedded In Tissue or Plaque2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 14, 2021Break

    ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1407LP LOW PROFILE REAMER FRAGMENT WAS BROKEN OFF AND LEFT INSIDE THE PATIENT. THIS WAS DISCOVERED DURING POST-OP CLEANING. THE SURGICAL TECHNICIAN NOTICED THE PIECE OF THE REAMER WAS MISSING. THE PATIENT WAS TAKEN TO X-RAY AND THE FRAGMENT WAS FOUND ON X-RAY.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 12466767 ↗
  • InjuryNov 13, 2018Break; Entrapment of Device

    IT WAS REPORTED THAT THE TIP OF THE REAMER BROKE IN THE SHOULDER BONE DURING A PROXIMAL BICEPS TENODESIS. THE SURGEON HAD PREDRILLED WITH 3.2 DRILL. THE TIP WAS NOT RETRIEVED FROM THE PATIENT; THE CASE WAS COMPLETED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8063894 ↗

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Sources and updates

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