Arthrex® AR-613-98Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00888867116955), received between Jun 30, 2021 and Nov 27, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Break; Break

  ON 11/05/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-613-98 IBALANCE TKA SMALL IMPACTOR BROKE DURING USE. ALL PIECES WERE RECOVERED, AND ANOTHER AR-613-98 IBALANCE TKA SMALL IMPACTOR WAS USED TO FINISH THE CASE WITHOUT FURTHER INCIDENT. THIS WAS DISCOVERED DURING TOTAL KNEE PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800512 ↗
• MalfunctionJun 3, 2024Crack; Crack

  ON 1/18/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-98 SMALL IMPACTOR CRACKED DURING A CASE. IT CRACKED WHILE PUTTING IN A POLY INSERT. NO PIECES WERE LEFT IN THE PATIENT. ANOTHER INSTRUMENT WAS USED TO FINISH THE CASE WITH NO FURTHER ISSUES. ADDITIONAL INFORMATION. THE IMPACTOR CRACKED DURING USE AND NOTHING BROKE FROM IT INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454398 ↗
• MalfunctionMay 27, 2024Break; Break

  ON 04/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT QTY. 2 OF AN AR-613-98 IBALANCE¿ TKA, SMALL IMPACTOR HAD AN ISSUE. THE SURGEON WAS DOING A TKA ON (B)(6) 2022 AND WHILE USING THE SMALL IMPACTOR THE TIP BROKE OFF OF TWO OF THEM. THEY OPENED ANOTHER INSTRUMENT SET AND GOT ANOTHER ONE TO FINISH THE CASE WITH. THAT ONE WORKED AND THE CASE WAS FINISHED WITHOUT FURTHER INCIDENT. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 04/26/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THE TWO COMPLAINT DEVICES SPLIT IN HALF AND BROKE OUTSIDE OF THE PATIENT, FELL ON THE FLOOR, AND ALL FRAGMENTS WERE RETRIEVED. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402339 ↗
• MalfunctionMay 24, 2024Break; Break

  ON 10/26/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-98 SMALL IMPACTOR BROKE. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2021. SURGEON USED ANOTHER IMPACTOR TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19398037 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT TWO AR-613-98 IBALANCE TKA,SMALL IMPACTOR HEADS WERE BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 19285343 ↗
• MalfunctionDec 8, 2023Break; Break

  ON 11/14/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS-06401414 THAT AN AR-613-98 IBALANCE¿ TKAS PLASTIC FROM THE FISH MOUTH SNAPPED OFF. THIS OCCURRED DURING A TOTAL KNEE PROCEDURE WHERE NOTHING ENTERED THE PATIENT. THE BROKEN PIECE FELL TO THE FLOOR. THE CASE WAS COMPLETED WITH A NEW TRAY.

  Patient problems: Insufficient Information

  MAUDE report 18292619 ↗
• MalfunctionNov 22, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT A (QTY. 3) OF AN AR-613-98 IBALANCE TKA, SMALL IMPACTOR IS BROKEN AND WAS DISCARDED. THE CASE WAS FINISHED WITH ANOTHER IMPACTOR WITH NO PATIENT INVOLVEMENT. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION HAS BEEN REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190257 ↗
• MalfunctionNov 22, 2023Break; Break

  ON 10/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06067102 THAT A (QTY. 3) OF AN AR-613-98 IBALANCE TKA, SMALL IMPACTOR IS BROKEN AND WAS DISCARDED. THE CASE WAS FINISHED WITH ANOTHER IMPACTOR WITH NO PATIENT INVOLVEMENT. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON 10/25/2023. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190245 ↗
• MalfunctionNov 22, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT A (QTY. 3) OF AN AR-613-98 IBALANCE TKA, SMALL IMPACTOR IS BROKEN AND WAS DISCARDED. THE CASE WAS FINISHED WITH ANOTHER IMPACTOR WITH NO PATIENT INVOLVEMENT. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190222 ↗
• MalfunctionMay 11, 2023Break; Break

  ON 4/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-98 IBALANCE TKA SMALL IMPACTOR BROKE IN HALF AND (QTY. 2) OF AN AR-623-3 IBALANCE TKA TORQUE DRIVER WAS TWISTED. ANOTHER AR-613-98 IBALANCE TKA SMALL IMPACTOR WAS USED TO FINISH THE CASE WITHOUT FURTHER INCIDENT, AND NO PIECES WERE LEFT IN THE PATIENT. ANOTHER AR-623-3 IBALANCE TKA TORQUE DRIVER WAS ALSO USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN TKA PROCEDURE ON (B)(6) 2023, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913145 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-98 IMPACTOR BROKE IN HALF. CASE INVOLVEMENT, THE DEVICE BROKE DURING USE. ANOTHER IMPACTOR WAS USED TO FINISH THE CASE WITHOUT FURTHER INCIDENT.

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

  MAUDE report 16544778 ↗
• MalfunctionJan 9, 2023Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-98 IMPACTOR BROKE IN HALF. CASE INVOLVEMENT, NO PATIENT EFFECT. PER FACILITY: "WHILE USING THE SMALL IMPACTOR IT BROKE IN HALF. WE THEN GOT ANOTHER ONE AND IT BROKE AS WELL. WE GOT ANOTHER AND FINISHED THE CASE WITHOUT FURTHER INCIDENT. NO PIECES FELL IN THE PATIENT AND ALL WERE RETRIEVED. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120513 ↗
• MalfunctionMay 16, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-613-98 TKA SMALL IMPACTOR BROKE. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2022. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407142 ↗
• MalfunctionMay 16, 2022Break

  ON 04/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-613-98 TKA SMALL IMPACTOR BROKE. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2022. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407125 ↗
• MalfunctionApr 25, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-613-98 IBALANCE TKA BROKE IN HALF. THIS OCCURRED DURING A TKA WHILE THE SURGEON WAS PUTTING IN A TRIAL POLY, THE SMALL IMPACTOR BROKE IN HALF. NO FRAGMENTS FELL INTO THE PATIENT. ANOTHER IMPACTOR WAS USED TO FINISH THE CASE, AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194329 ↗
• MalfunctionDec 21, 2021Break

  ON 11/29/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT A AR-613-98 IBALANCE TKA BROKE. THIS WAS DISCOVERED ON (B)(6) 2021 DURING A TKA WHEN THE SURGEON WAS USING THE SMALL IMPACTOR AND THE METAL COUPLING DEVICE BROKE. THE BROKEN FRAGMENTS WERE RETRIEVED, AND ANOTHER IMPACTOR WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 13054933 ↗
• MalfunctionNov 16, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-613-98 SMALL IMPACTOR TIPS BROKE DURING USE. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6)2021. A THIRD IMPACTOR WAS USED TO FINISHED CASE WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 12819008 ↗
• MalfunctionNov 16, 2021Break

  ON 10/27/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-613-98 SMALL IMPACTOR TIPS BROKE DURING USE. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2021. A THIRD IMPACTOR WAS USED TO FINISHED CASE WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 12819005 ↗
• MalfunctionAug 24, 2021Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN THE SURGEON WAS IMPACTING THE TRIAL POLY, THE TIP OF THE AR 613-98 BROKE. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING ANOTHER.

  Patient problems: Insufficient Information

  MAUDE report 12362304 ↗
• MalfunctionJun 30, 2021Break

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN THE SURGEON WAS IMPACTING THE TRIAL POLY, THE TIP OF THE AR 613-98 BROKE. THE CASE WAS COMPLETED BY USING ANOTHER INSTRUMENT SET TO GET ANOTHER IMPACTOR.

  Patient problems: Insufficient Information

  MAUDE report 12091667 ↗