Arthrex® AR-613-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867115941), received between Mar 12, 2021 and Jun 18, 2024 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Break; Break

  ON 02/22/2022 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT A AR-613-1 IBALANCE TKA 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 19560075 ↗
• MalfunctionJun 18, 2024Break; Break

  ON 02/01/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-613-1 HANDLE BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A TKA PROCEDURE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559333 ↗
• MalfunctionJun 7, 2024Fracture; Fracture

  ON 04/19/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-613-1 IBALANCE¿ TKA, HANDLE, MODULAR KEEL PUNCH HAD AN ISSUE. THE SURGEON WAS DOING A TKA PROCEDURE ON (B)(6) 2022 AND WHILE USING THE KEEL PUNCH HANDLE, THE BLUE PART OF THE HANDLE CRACKED. THEY GOT ANOTHER ONE FROM ANOTHER INSTRUMENT SET AND FINISHED THE CASE WITHOUT FURTHER INCIDENT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492942 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED THAT THE AR-613-1 BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477825 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED ON 08/05/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-1 HANDLE CRACKED. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472801 ↗
• MalfunctionJun 5, 2024Break; Break

  ON 05/03/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-613-1 HANDLE IS CRACKED. THIS WAS DISCOVERED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471909 ↗
• MalfunctionJun 4, 2024Crack; Crack

  ON 12/07/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-613-1 IBALANCE¿ TKA HANDLE WAS CRACKED. THIS WAS DISCOVERED DURING A CASE ON (B)(6) 2022. ANOTHER SET AND HANDLE WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457195 ↗
• MalfunctionJun 1, 2024Fracture; Fracture

  ON 04/04/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-1 IBALANCE¿ TKA CRACKED. THIS OCCURRED DURING A TKA ON (B)(6) 2023 AND THE HANDLE CRACKED. NO PART OF THE DEVICE BROKE INSIDE OF THE PATIENT AND THE CASE WAS COMPLETED USING ANOTHER AR-613-1. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441788 ↗
• MalfunctionMay 24, 2024Use of Device Problem; Use of Device Problem

  ON 2/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-65 DUAL SPIKE PUNCH PEG BROKE OFF AND AN AR-613-1 HANDLE WON'T ENGAGE PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 2/21/2023: THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2023 AND COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THE DUAL SPIKE PUNCH HAD A PIECE OF THE CONNECTOR BROKE OFF WHEN UNHOOKING IT FROM THE HANDLE, ALL THE BROKEN FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390284 ↗
• MalfunctionMay 23, 2024Fracture; Fracture

  ON 05/05/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A AR-613-1 KEEL PUNCH HANDLE IS CRACKED, DECLARING THE DEVICE UNUSABLE FOR USE. THIS WAS DISCOVERED DURING AN UNKNOWN TIME WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383719 ↗
• MalfunctionMay 23, 2024Fracture; Fracture

  ON 04/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-613-1 IBALANCE¿ TKA, HANDLE, MODULAR KEEL PUNCH HAD AN ISSUE. THE SURGEON WAS DOING A TKA PROCEDURE ON (B)(6) 2022 AND NOTICED THAT THE HANDLE WAS CRACKED AND THE SPRING MECHANISM ON THE QUICK CONNECT WAS TOO LOOSE AND NEEDED TO BE REPLACED. THE CASE WAS FINISHED WITH ANOTHER ONE AND WITHOUT FURTHER INCIDENT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383698 ↗
• MalfunctionMay 23, 2024Crack; Crack

  IT WAS REPORTED THAT THE AR-613-1 CRACKED DURING INSERTION DURING A TKA PROCEDURE. THE REP REPORTED THE DEVICE DID NOT BREAK INTO DISCRETE PIECES. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER TRAY. THE CASE WAS COMPLETED SUCCESSFULLY. SEE ATTACHED IMAGES.

  Patient problems: Insufficient Information

  MAUDE report 19383634 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 11/01/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT (2) AR-613-1 HANDLES ARE BROKEN. THIS OCCURRED IN A CASE WHEN THE CONNECTING END PIECE BROKE OFF. ALL PIECES WERE RETRIEVED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380721 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 11/01/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT (2) AR-613-1 HANDLES ARE BROKEN. THIS OCCURRED IN A CASE WHEN THE CONNECTING END PIECE BROKE OFF. ALL PIECES WERE RETRIEVED. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380634 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE AR-613-1 IS CRACKED. THE ISSUE WAS DISCOVERED UPON INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370514 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT THE AR-613-1 IS BROKEN. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148406 ↗
• MalfunctionFeb 5, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ON 01/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-613-1 KEEL PUNCH HAS A BROKEN HANDLE, AND AN AR-613-1 KEEL PUNCH HAS A LOOSE SPRING. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641210 ↗
• MalfunctionFeb 5, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-613-1 KEEL PUNCH HAS A BROKEN HANDLE, AND AN AR-613-1 KEEL PUNCH HAS A LOOSE SPRING. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641157 ↗
• MalfunctionNov 28, 2023Break; Break

  ON 11/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-613-1 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH, AND AN AR-623-6 IBALANCE TKA, KEEL PUNCH, SIZE 4-7 HAD AN ISSUE. THE HANDLE AND TIBIAL KEEL PUNCH CONNECTION BROKE OFF. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INFORMATION, AND NO PIECES BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON 11/2/2023, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 11/7/2023: AR-613-1 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH, AND AN AR-623-6 IBALANCE TKA, KEEL PUNCH BROKE OFF INSIDE THE PATIENT WITH ALL FRAGMENTS RETRIEVED FROM THE PATIENT. THE METAL PIECE THAT BROKE OFF THE KEEL PUNCH IS INSIDE THE TKA HANDLE. THE CASE WAS DELAYED 2 MINUTES AND COMPLETED USING PLYERS TO GET THE SIZE 4-7 KEEL PUNCH OUT OF THE PATIENT'S TIBIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221659 ↗
• MalfunctionAug 30, 2023Break; Break

  ON 8/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (QTY.2) AR-613-1 TKA HANDLES BROKE. THIS OCCURRED WHILE IMPACTING THE PS CHISEL AND TIBIAL KEEL IMPACTOR. THE BROKEN PIECES WERE LOST IN THE DECONTAMINATION PROCESS. THIS WAS DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17651389 ↗
• MalfunctionAug 29, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (QTY.2) AR-613-1 TKA HANDLES BROKE. THIS OCCURRED WHILE IMPACTING THE PS CHISEL AND TIBIAL KEEL IMPACTOR. THE BROKEN PIECES WERE LOST IN THE DECONTAMINATION PROCESS. THIS WAS DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17645793 ↗
• MalfunctionAug 25, 2023Break; Crack; Break; Crack

  ON 7/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-1 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH HAS A CRACKED SHAFT. IT WAS INVOLVED IN A CASE. PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624657 ↗
• MalfunctionAug 17, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-1 IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH HAD AN ISSUE. DURING A TKA PROCEDURE ON (B)(6) 2023, THE SURGEON NOTICED THE HANDLE ON THE KEELED QUICK CONNECT WAS CRACKED. THE CASE WAS FINISHED WITH ANOTHER AR-613-1. THIS WAS DISCOVERED DURING USE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17566778 ↗
• MalfunctionMar 2, 2023Break

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-1 TKA HANDLE BROKE. CASE INVOLVEMENT, DEVICE BROKE DURING USE. ALL FRAGMENTS REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466128 ↗
• MalfunctionFeb 6, 2023Break

  IT WAS REPORTED ON 01/18/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-1 HANDLE BROKE WHILE EXTRACTING POLY TRIAL. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 16303026 ↗