Arthrex® AR-18716-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867313231), received between Mar 12, 2021 and Sep 9, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07039383 THAT AN AR-18716-11 AND A AR-18716-10 LOW PROFILE SCREWS BROKE WHILE BEING IMPLANTED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004612 ↗
• MalfunctionAug 5, 2025Break; Defective Device; Break; Defective Device

  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: Foreign Body In Patient

  MAUDE report 22719822 ↗
• MalfunctionJun 3, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN (QTY. (B)(4)) OF AN AR-18716-11 LOW PROFILE CORTICAL SCREW AND AN AR-18716V-12 VAL SCREW BROKE OFF DURING IMPLANTATION OF THE SCREW INTO A PLATE. EACH SCREW BROKE AT THE NECK WHILE THEY WERE SCREWING INTO THE PLATE, LEAVING THE SHAFT OF THE SCREW IN THE BONE, AS REMOVAL COULD NOT BE EXTRACTED. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE ORIF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 22133652 ↗
• MalfunctionJun 3, 2025Break; Break

  ON 05/12/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN (QTY. 2) OF AN AR-18716-11 LOW PROFILE CORTICAL SCREW AND AN AR-18716V-12 VAL SCREW BROKE OFF DURING IMPLANTATION OF THE SCREW INTO A PLATE. EACH SCREW BROKE AT THE NECK WHILE THEY WERE SCREWING INTO THE PLATE, LEAVING THE SHAFT OF THE SCREW IN THE BONE, AS REMOVAL COULD NOT BE EXTRACTED. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE ORIF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 06/02/2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 22133158 ↗
• MalfunctionNov 30, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18716-08, AN AR-18716-09, AND AN AR-18716-11 CORTICAL SCREWS BROKE ON THE FILE TIGHTENING OF THE SCREW. THIS WAS DISCOVERED DURING A PROCEDURE, THE SCREWS REMAIN INSIDE THE PATIENT. ADDITIONAL INFORMATION REQUESTED. AFTER RECEIVING ADDITIONAL INFORMATION ON (B)(6) 2021, SALES REPRESENTATIVE HAS CONFIRMED THAT DURING THE METACARPAL FRACTURE PROCEDURE, THREE CORTICAL SCREW BROKE AND REMAINED IN PATIENT. SURGEON USED A 1.2MM DRILL BIT TO PREPARE BONE TUNNELS AND PUT IN NEW SCREWS IN OTHER HOLES OF THE PLATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12897327 ↗
• MalfunctionMar 12, 2021Break

  IT WAS REPORTED BY THE SALES REP, THAT DURING A METACARPAL FRACTURE, THE AR-18716-11 BROKE UPON INSERTION. ADDITIONAL INFORMATION PROVIDED 2/26/21: ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CORRESPONDING DRILL BIT FOR THE 1.6MM SCREWS WAS USED PRIOR TO INSERTION (1.2MM DRILL BIT). THE PATIENT WAS IN UPPER 20S WITH HEALTHY BONE QUALITY. AFTER REMOVAL OF THE BROKEN SCREW, A NEW SCREW OF SIMILAR SIZE WAS USED TO COMPLETE PLATE FIXATION.

  Patient problems: Failure of Implant

  MAUDE report 11475260 ↗