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
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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