Arthrex® AR-18714-08Recalls & reported problems
Arthrex, Inc. · Low Profile Screw, 1.4x8mm, Cortical, Ti · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867303874), received between Apr 18, 2022 and Jun 9, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Most reported problems
Device problems
- Break3
- Difficult to Insert1
- Entrapment of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2023Break; Break
ON 5/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18714-07 LOW PROFILE SCREW AND AN AR-18714-08 LOW PROFILE SCREW BROKE DURING INSERTION INTO THE PLATE. THIS WAS DISCOVERED DURING A METACARPAL FX PROCEDURE ON (B)(6) 2023. THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 17099873 ↗MalfunctionNov 21, 2022Break; Entrapment of Device; Difficult to Insert
ON 10/31/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-18714-08, AR-18714-07, AND A AR-18714-09 SCREW BROKE. THIS OCCURRED DURING A PHALANX FRACTURE ON (B)(6) 2022 WHEN INSERTING THE AR-18714-08 SCREW IT BROKE ABOUT 3/4 OF THE WAY, THE SURGEON THEN ATTEMPTED TO INSERT A AR-18714-09 SCREW TO SECURE THE PLATE TO THE BONE, UPON INSERTION THE SCREW BROKE. THEN A AR-18714-07 SCREW WAS USED TO SECURE THE PLATE AS IT WAS ALREADY DOWN, WHEN ATTEMPTING TO SECURE THE PLATE IT BROKE. ALL BROKEN FRAGMENTS REMAIN IN THE PATIENT. THE PATIENT HAD VERY GOOD BONE QUALITY AND THE SOCKETS WERE PREPPED FOR INSERTION WITH A AR-18700-06 DRILL BIT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15833639 ↗MalfunctionApr 18, 2022Break
ON 3/30/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-18714-08 LOW PROFILE SCREW HEAD BROKE OFF. THE SCREW HEAD WAS REMOVED AND THE BODY REMAINS IMPLANTED IN THE PATIENT. THIS WAS DISCOVERED DURING A PHALANX ORIF PROCEDURE ON (B)(6) 2022
Patient problems: Insufficient Information
MAUDE report 14135702 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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