Arthrex® AR-18700-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867312746), received between Dec 27, 2021 and Jun 14, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Break; Break

  IT WAS REPORTED THAT ONE OF THE FOUR "CLAWS" ON THE AR-18700-25 HOLDING SLEEVE USED TO PULL THE SCREWS BROKE OFF. SEE SOURCE DATA AND IMAGE ATTACHED. THE ISSUE OCCURRED DURING A METACARPAL FRACTURE PROCEDURE, BUT DID NOT AFFECT THE SURGERY AT ALL. ALL THAT BROKE WAS THE SCREW HOLDING SLEEVE WHICH JUST MADE IT A LITTLE LESS EASY TO GRAB SCREWS. THE REP REPORTED THIS DEVICE DOES NOT GO INTO OR NEAR THE PATIENT. THE PIECE THAT BROKE GOT THROWN AWAY BY THE TECH. NO UNPLANNED INCISIONS AND THE CASE WAS COMPLETED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536238 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-25 HOLDING SLEEVE WAS JAMMED IN THE CADDY, BENT AND BROKE. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390296 ↗
• MalfunctionMay 15, 2024Break; Break

  IT WAS REPORTED THAT THE AR-18700-25 HOLDING SLEEVE IS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19322106 ↗
• MalfunctionJan 4, 2022Break; Degraded

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-49, THE PLASTIC LOBSTER CLAWS SNAPPED, AND THE AR-18700-25 SCREW FROM THE HOLDING SLEEVE RUSTED THROUGH. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. NO PATIENT AFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. REQUESTED ADDITIONAL INFORMATION 12/15/2021. ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THE PLASTIC LOBSTER CLAW WASN¿T CLAMPING AND WAS FALLING APART DURING USE. THE SCREW RETENTION SLEEVE FALL INTO TWO PIECES. THE CASE WAS ON (B)(6) WITH DR. (B)(6) FINGER FRACTURE. THE CASE WAS COMPLETED USING JUST AN EXTERNAL FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154799 ↗
• MalfunctionDec 27, 2021Break

  ON 12/07/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-18700-49 CLAMP, AND A R-18700-25 SLEEVE ARE BROKEN. THIS OCCURRED ON (B)(6) 2021 DURING A PROCEDURE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13087984 ↗