Arthrex® AR-623-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867229938), received between Nov 8, 2021 and Jun 14, 2024 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Crack; Crack

  IT WAS REPORTED DURING A TKA PROCEDURE, WHILE IMPACTING, THE AR-623-36 QUICK CONNECT IMPACTOR CRACKED. NO PIECE BROKE OFF FROM THE DEVICE, AND THE CASE WAS COMPLETED WITHOUT ISSUE. SEE SOURCE DATA ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19539395 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 10/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-623-36 HANDLE IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380530 ↗
• MalfunctionMay 20, 2024Break; Break

  ON 07/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-623-36 IBAL TKA TIBIAL IMPACTOR, SOLID HANDLE, WAS BROKEN. THIS OCCURRED DURING A TKA PROCEDURE, NO PIECE BROKE OFF INSIDE THE PATIENT, AND NO BROKEN PIECE NEEDED TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 08/05/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THE BLUE TOP PART OF THE HANDLE CRACKED AND SPLIT DOWN THE MIDDLE OUTSIDE OF THE PATIENT, NOTHING BROKE OFF OR FELL APART. THAT PART OF THE PROCEDURE WAS COMPLETED, THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED AND THE DEVICE WAS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352489 ↗
• MalfunctionApr 18, 2024Break; Break

  ON 3/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06523645 THAT AN AR-623-36 IBALANCE TKA, TIBIAL IMPACTOR AND AN AR-623-T812 IBALANCE TKA, TIBIAL BEARING TRIAL SIZE 8 BROKE DURING USE WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140599 ↗
• MalfunctionMar 20, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON 03/6/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-623-36 IBALANCE TKA, TIBIAL IMPACTOR PLASTIC PIECE SPLIT INTO TWO PIECES. THIS WAS WHEN THE SURGEON WAS IMPACTING THE TIBIAL COMPONENT. NOTHING BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18945491 ↗
• MalfunctionAug 31, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-623-7 KEEL PUNCH AND AN AR-623-36 TIBIAL IMPACTOR BROKE. THIS OCCURRED DURING A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023, THE TAPER ON THE KEEL PUNCH SNAPPED OFF WHEN TRYING TO REMOVE IT FROM THE BONE. THE TIBIAL IMPACTOR BROKE DURING THE IMPACTION OF THE IMPLANT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17662451 ↗
• MalfunctionOct 31, 2022Break

  ON 10/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-623-36 TIBIAL IMPACTOR BROKE. THIS OCCURRED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE WHEN THE DEVICE BROKE, THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698212 ↗
• MalfunctionNov 8, 2021Structural Problem

  ON 09/30/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-93 WOULD NOT HOLD REDUCTION AND WOULD NOT FULLY LOCK DURING A TKA PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW AR-613-93. AFTER PUTTING THE SET AWAY, THE FACILITY NOTICED THAT AN AR-623-36 WAS NOTED TO BE "CHEWED UP" ON ONE EDGE. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770423 ↗