Arthrex® AR-8950RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867133259), received between Apr 8, 2020 and Oct 20, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionOct 20, 2025Positioning Failure; Positioning Failure

  ON 10/14/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8950RH RATCHETING HANDLE STOPPED RATCHETING DURING A CASE, CAUSING THE DOCTOR TO OVER-TORQUE A SCREW. HAPPENED DURING A CASE AND WAS COMPLETED SUCCESSFULLY WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336463 ↗
• MalfunctionMay 27, 2024Corroded; Corroded

  IT WAS REPORTED ON 12/08/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8950RH HANDLE IS RUSTED ON THE INSIDE. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400195 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 07/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-8950RH RATCHETING HANDLE IS BROKEN. THIS WAS DISCOVERED DURING AN UNKNOWN TIME WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383768 ↗
• InjuryApr 8, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PILON FRACTURE PROCEDURE THE REP HAD TO GO THROUGH MULTIPLE TRAYS TO FIND A WORKING AR-8950RH RATCHETING HANDLE. A QUANTITY THREE AR-8950RH WOULD NOT RATCHET EITHER WAY. DURING THE SAME PROCEDURE THE TIP OF THE AR-13120G-2, MINI DEPTH GUIDE SNAPPED OFF AND A SECOND ONE HAD TO BE OPENED. THE SALES REP REPORTED THE CASE WAS COMPLETED AND THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 03/18/2020: THE REP REPORTED ALL BROKEN PIECES WERE FULLY ACCOUNTED FOR AS NO PIECES BROKE WHILE IN THE PATIENT. THE DEPTH GUIDE NEEDLE BROKE AND WENT FLYING INTO THE CORNER OF THE OR, AND THE RATCHETING HANDLES WERE DISCOVERED BROKEN BEFORE THEY WERE USED ON THE PATIENT. THE SALES REP REPORTED THE CASE TOOK LONGER THAN EXPECTED SO THE PATIENT WAS UNDOUBTEDLY EXPOSED TO A LONGER DOSE OF ANESTHESIA. THE CASE WAS COMPLETED BY USING THE DEPTH GAUGE FROM THE 3.0MM INSTRUMENT CADDY AS IT FITS IN THE HOLES DRILLED WITH A 1.7MM DRILL BIT.

  Patient problems: Overdose

  MAUDE report 9935417 ↗
• InjuryApr 8, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PILON FRACTURE PROCEDURE THE REP HAD TO GO THROUGH MULTIPLE TRAYS TO FIND A WORKING AR-8950RH RATCHETING HANDLE. A QUANTITY THREE AR-8950RH WOULD NOT RATCHET EITHER WAY. DURING THE SAME PROCEDURE THE TIP OF THE AR-13120G-2, MINI DEPTH GUIDE SNAPPED OFF AND A SECOND ONE HAD TO BE OPENED. THE SALES REP REPORTED THE CASE WAS COMPLETED AND THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 03/18/2020: THE REP REPORTED ALL BROKEN PIECES WERE FULLY ACCOUNTED FOR AS NO PIECES BROKE WHILE IN THE PATIENT. THE DEPTH GUIDE NEEDLE BROKE AND WENT FLYING INTO THE CORNER OF THE OPERATING ROOM, AND THE RATCHETING HANDLES WERE DISCOVERED BROKEN BEFORE THEY WERE USED ON THE PATIENT. THE SALES REP REPORTED THE CASE TOOK LONGER THAN EXPECTED SO THE PATIENT WAS UNDOUBTEDLY EXPOSED TO A LONGER DOSE OF ANESTHESIA. THE CASE WAS COMPLETED BY USING THE DEPTH GAUGE FROM THE 3.0MM INSTRUMENT CADDY AS IT FITS IN THE HOLES DRILLED WITH A 1.7MM DRILL BIT.

  Patient problems: No Code Available

  MAUDE report 9935386 ↗
• InjuryApr 8, 2020Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PILON FRACTURE PROCEDURE THE REP HAD TO GO THROUGH MULTIPLE TRAYS TO FIND A WORKING AR-8950RH RATCHETING HANDLE. A QUANTITY THREE AR-8950RH WOULD NOT RATCHET EITHER WAY. DURING THE SAME PROCEDURE THE TIP OF THE AR-13120G-2, MINI DEPTH GUIDE SNAPPED OFF AND A SECOND ONE HAD TO BE OPENED. THE SALES REP REPORTED THE CASE WAS COMPLETED AND THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 03/18/2020: THE REP REPORTED ALL BROKEN PIECES WERE FULLY ACCOUNTED FOR AS NO PIECES BROKE WHILE IN THE PATIENT. THE DEPTH GUIDE NEEDLE BROKE AND WENT FLYING INTO THE CORNER OF THE OR, AND THE RATCHETING HANDLES WERE DISCOVERED BROKEN BEFORE THEY WERE USED ON THE PATIENT. THE SALES REP REPORTED THE CASE TOOK LONGER THAN EXPECTED SO THE PATIENT WAS UNDOUBTEDLY EXPOSED TO A LONGER DOSE OF ANESTHESIA. THE CASE WAS COMPLETED BY USING THE DEPTH GAUGE FROM THE 3.0MM INSTRUMENT CADDY AS IT FITS IN THE HOLES DRILLED WITH A 1.7MM DRILL BIT.

  Patient problems: Overdose

  MAUDE report 9935370 ↗