Arthrex® AR-18716P-18Recalls & reported problems
Arthrex, Inc. · T-Plate, 1.6mm, 8 Hole · Class 2 · Implant
Data updated Oct 18, 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 00888867313507), received between Aug 5, 2025 and Aug 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Positioning Failure1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Positioning Failure; Positioning Failure
ON 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-18716-11 CORTICAL SCREW BROKE DURING REMOVAL. AFTER PLACING ALL SCREWS AND A PLATE, THE CONSTRUCT WAS EVALUATED VIA X-RAY, AND IT WAS DETERMINED THAT THE 11 MM SCREW WAS TOO LONG. THE SURGEON ATTEMPTED TO BACK OUT THE SCREW TO REPLACE IT WITH A SHORTER ONE, BUT THE SCREW FRACTURED DURING REMOVAL. THE BREAK OCCURRED BELOW THE PLATE, MAKING REMOVAL NOT FEASIBLE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THIS OCCURRED DURING A METACARPAL ORIF PROCEDURE. AN AR-18716P-18 T-PLATE (LOT 105642321) WAS SUCCESSFULLY IMPLANTED. NO DAMAGE HAPPENED TO THE PLATE, AND NO SURGICAL INSTRUMENTS BROKE DURING REMOVAL. HOWEVER, ONE AR-18716-11 CORTICAL SCREW FRACTURED AND REMAINED IN THE BONE. THE CORRECT DRIVER WAS USED CONSISTENTLY THROUGHOUT THE PROCEDURE AND FUNCTIONED PROPERLY ON THE REMAINING SIX SCREWS. THE LOT NUMBER FOR THE BROKEN SCREW IS UNKNOWN. THERE WAS NO CHANGE IN SURGICAL TECHNIQUE, AND NO ADDITIONAL PRODUCTS WERE USED TO COMPLETE THE CASE. A DELAY OF APPROXIMATELY FIVE MINUTES OCCURRED, BUT NO EXTRA ANESTHESIA WAS ADMINISTERED. THE AR-18700-12 DRILL BIT WAS USED TO PREP
Patient problems: Insufficient Information
MAUDE report 22720562 ↗
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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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