Arthrex® AR-13120G-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867007727), received between Apr 8, 2020 and Feb 21, 2025 — classified as 1 injury, 8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Break; Break

  ON 02/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06776294 THAT AN AR-13120G-2 DEPTH GUIDE BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE BROKEN PIECE WAS REMOVED AND DID NOT AFFECT THE CASE OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431649 ↗
• MalfunctionFeb 8, 2024Break; Break

  ON 01/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13120G-2 DEPTH GUIDE MINI TIP BROKE OFF. THIS OCCURRED DURING A DISTAL RADIUS FRACTURE WHEN THE SURGEON WAS PLACING HIS DISTAL ROW OF SCREWS WITH 2.4 VARIABLE LOCKING SCREWS. AFTER DRILLING FOR THE 3RD DISTAL SCREW, THE GOLD DRILL SLEEVE WAS REMOVED, AND THE SURGEON INSERTED THE DEPTH GAUGE FOR THE 2.4 SCREWS (AR-13120G-2) INTO THE PLATE AND THROUGH THE DRILL HOLE. THE SURGEON THEN TRIED TO GET A MEASUREMENT, AND THE TIP OF THE DEPTH GAUGE BROKE OFF INTO THE PATIENT. THE BROKEN FRAGMENTS WAS RETRIEVED FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18669128 ↗
• MalfunctionJul 6, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 06/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13120G-2 MINI DEPTH GUIDE WAS BENT AND MISSING THE HOOK. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17270438 ↗
• MalfunctionAug 8, 2022Break

  ON (B)(6)2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-13120G-2 DEPTH GUIDES TIP OF THE WIRE BROKE OFF. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15183294 ↗
• MalfunctionJul 25, 2022Break

  ON (B)(6) 2022 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13120G-2 DEPTH GAUGE BROKE DURING REGULAR USAGE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022 . ADDITIONAL INFORMATION REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 15093436 ↗
• MalfunctionJul 18, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-13120G-2 DEPTH GUIDE, MINI HAD AN ISSUE, AS IT WAS BEING USED IT SNAPPED IN HALF, NO HARM TO THE PATIENT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042011 ↗
• MalfunctionJul 5, 2022Detachment of Device or Device Component

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-13120G-2 DEPTH GAUGE TIP SNAPPED OFF. ANOTHER DEPTH GAUGE FROM A MINI CFS SET WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ORIF DISTAL RADIUS ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14914763 ↗
• MalfunctionApr 12, 2021Fracture; Device Slipped

  IT WAS REPORTED THAT THE TOP PART OF THE DEPTH GUIDE FELL OFF WHEN THE SURGEON WENT TO MEASURE THE DRILL HOLE FOR AN IMPLANT. THE TIP WAS REMOVED FROM THE PATIENT AND THE DISTAL RADIUS FRACTURE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 11648182 ↗
• InjuryApr 8, 2020Break

  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 Consequences Or Impact To Patient

  MAUDE report 9935341 ↗