Arthrex® AR-613-91Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867116900), received between Jul 3, 2023 and Nov 27, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Break; Break

  ON 11/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-613-91 IBALANCE TKA PIN DRIVER HAD THE PIN BREAK OFF INSIDE THE PIN DRIVER AND, THEREFORE, WAS NOT ABLE TO BE UTILIZED DURING THE SECOND HALF OF THE PROCEDURE. THE CASE CONTINUED, AND ANOTHER PRODUCT FROM THE SECOND INSTRUMENT SET WAS USED. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 11/06/2024: THIS WAS DISCOVERED DURING A UNI KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797224 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 08/23/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A PIN DRIVER IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380400 ↗
• MalfunctionJul 12, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A UKA STABILIZING PIN (AR-613-50) BROKE INSIDE OF THE PIN DRIVER (AR-613-91). THE BROKEN PIN WAS UNABLE TO BE REMOVED FROM THE PIN DRIVER DEEMING IT UNUSABLE DURING THE CASE. AND A TIBIAL IMPACTOR (AR-611-4) TIP BROKE OFF UPON IMPACTING THE TIBIAL TRIAL. THIS WAS DISCOVERED DURING A CASE, DEVICES BROKE DURING USE. ALL FRAGMENTS ABLE TO BE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 17304693 ↗
• MalfunctionJul 3, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-91 PIN DRIVER BROKEN. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17248198 ↗