Arthrex® AR-1998Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867025790), received between Mar 16, 2023 and May 13, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(6) THAT AN AR-1998 ANNULATED SCREWDRIVER SHAFT BROKE. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19298378 ↗
• MalfunctionMay 8, 2024Break; Break

  ON 04/15/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1998 HEX CANNULATED SCREWDRIVER SHAFT WAS BROKEN. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19272015 ↗
• MalfunctionMar 4, 2024Break; Break

  ON 2/16/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1998 CANNULATED SCREWDRIVER SHAFT BROKE DURING USE. THE CASE WAS COMPLETED USING ANOTHER SCREWDRIVER. ALL THE BROKEN FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 2/21/24: THE PROCEDURE PERFORMED WAS AN ANTERIOR LIGAMENT RECONSTRUCTION. THE SURGERY WAS COMPLETED WITHOUT ADDITIONAL ANESTHESIA. THE PATIENT HAD NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827346 ↗
• MalfunctionDec 8, 2023Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1998 CANNULATED SCREWDRIVER SHAFT TWISTED WHILE REMOVING A TITANIUM INTERFERENCE SCREW. THIS WAS DISCOVERED DURING A REVISION ACL PROCEDURE ON (B)(6) 2023. THE SCREW WAS FINALLY REMOVED WITH A PRODUCT FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE SALES REPRESENTATIVE DOES NOT KNOW WHEN THE ORIGINAL PROCEDURE OCCURRED BUT WAS TOLD IT WAS PERFORMED OVER THIRTEEN YEARS AGO. THE ORIGINAL PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE PART NUMBER FOR THE SCREW IS ALSO UNKNOWN, THE SALES REPRESENTATIVE BELIEVES IT COULD HAVE BEEN AN AR-1370H-25 SOFT SCREW, 7X 25 MM, OR AN AR-1380H-25 SOFT SCREW, 8 X 25 MM. THE REVISION SURGEON WAS PERFORMED BECAUSE THE PATIENT TORE THE ACL. DURING THE REVISION SURGERY, ONLY THE FEMORAL SCREW WAS REMOVED, AS THE TIBIAL SCREW WAS NOT IN THE WAY TO PERFORM THE REVISION SURGERY. THE SURGEON USED (2) AR-4020C-08 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 8 X 20 MM DURING THE REVISION SURGERY. ONE IN THE FEMUR AND THE OTHER IN THE TIBIA. THE REVISION SURGERY WAS ONLY DELAYED A FEW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18295937 ↗
• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED ON 02/24/2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1998 SCREWDRIVER SHAFT SNAPPED. CASE INVOLVEMENT, THE DEVICE BROKE DURING USE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16552653 ↗