Arthrex® AR-613-99Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867116962), received between Aug 18, 2021 and Sep 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-99 SLAP HAMMER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 8/29/2023: THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2023. THE SLAP HAMMER BROKE WHEN TAKING OFF THE CRUCIATE PREP GUIDE, BUT IT DID NOT BREAK OFF INSIDE THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-613-99 SLAP HAMMER. THE CASE WAS DELAYED FOR ABOUT TEN MINUTES BECAUSE THE INSTRUMENT HAD TO BE STERILIZED. THE PATIENT RECEIVED ADDITIONAL ANESTHESIA FOR THE EXTRA CASE TIME. NO PATIENT HARM OR SIGNIFICANT SYMPTOMS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743502 ↗
• MalfunctionAug 18, 2021Break

  IT WAS REPORTED THE AR-613-99, SLAP HAMMER IS BROKEN. ADDITIONAL INFORMATION 7/30/2021: IT WAS REPORTED BY THE SALES REP, DURING A TOTAL KNEE ARTHROPLASTY METAL ON THE TIP ON THE AR-613-99 SLAP HAMMER, CRACKED. THE DEVICE BROKE DURING SURGERY BUT NO PARTS REMAINED IN THE PATIENT. A BACK UP SET WAS OPENED FOR A REPLACEMENT INSTRUMENT.

  Patient problems: Insufficient Information

  MAUDE report 12335678 ↗