Arthrex® AR-4060SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867031302), received between May 14, 2024 and Feb 4, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 01/13/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-4060S PROTECTOR¿ MENISCUS SUTURING SET WAS CUTTING THE SUTURE WHICH SHOULD NOT HAVE HAPPENED. THIS OCCURRED DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 21306706 ↗
• MalfunctionNov 5, 2024Break; Break

  ON 10/22/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-4060S PROTECTOR¿ MENISCUS SUTURING SETS LOOP WAS BROKEN. THIS OCCURRED DURING AN ACL PROCEDURE ON (B)(6) 2024. THEE CASE CONTINUED WITH A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611064 ↗
• MalfunctionMay 14, 2024Defective Device; Defective Device

  ON 05/02/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT A AR-9803-90 ABLATOR, AND A AR-4060S SUTURING SET MALFUNCTIONED. THIS OCCURRED ON 04/22/2022 DURING AN UNKNOWN PROCEDURE WHEN USING THE AR-9803-90 THE TIP MELTED INTO THE SHAPE OF A J, IT WAS USED AT A TEMPERATURE OF 60/60. WHEN USING THE PROTECTOR, THE DOCTOR HAD TO FORCE THE THREAD THROUGH AS IT WAS GETTING STUCK. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED ON 05/13/2023, IT WAS REPORTED THAT THIS EVENT OCCURRED DURING A RESECTION OF CLAVICLE/ROTATOR CUFF RUPTURE/LABRAL INJURY. THERE WAS NO PATIENT EFFECT, OR INJURY DUE TO THIS INCIDENT. THE CASE WAS COMPLETED BY UNSENTING THE TIP WHILE IT WAS HOT AND USED IT ONLY ONCE TO FINISH. BUT IT REMAINED SOFT EVEN WHEN LOWERING THE SCALPEL TEMPERATURE TO 40 L 40.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310755 ↗