Arthrex® AR-8916-27Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867177628), received between Feb 21, 2019 and Nov 3, 2025 — classified as 1 injury, 3 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Use of Device Problem; Use of Device Problem

  ON 10/24/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8916-27 DRIVER IS NOT HOLDING THE SCREWS. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451922 ↗
• MalfunctionSep 10, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06641117 THAT AN AR-8916-27 RETAINING DRIVER TIP IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182136 ↗
• MalfunctionAug 26, 2024Break; Break

  ON 07/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-8916-27 HEXALOBE DRIVER TIP BROKE OFF IN THE PLATE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064157 ↗
• InjuryFeb 21, 2019Break

  ON (B)(6) 2019 IT WAS INITIALLY REPORTED THAT ON THAT DAY AN AR-8916-27 DRIVER WAS BEING USED DURING A PROCEDURE AND THE DISTAL TIP STRIPPED. THE DRIVER WAS FROM SET AR-8950S (SERIAL NUMBER (B)(4)). ADDITIONAL INFORMATION PROVIDED 2/5/2019: THE PROCEDURE BEING PERFORMED WAS A TRI-MALLEOLAR ON THE POSTERIOR ANKLE. THE DISTAL TIP OF THE DRIVER STRIPPED AND BROKE-OFF IN THE HEX END OF THE SCREW. THE TIP BROKE-OFF AND THE TIP FRAGMENT IS FLUSH WITH THE FACE OF THE SCREW IN THE SCREW HEAD. THE SCREW WITH FRAGMENT WAS LEFT IN THE PATIENT. A BACK-UP T8 DRIVER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8357221 ↗