Arthrex® AR-4160FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867032996), received between Feb 23, 2023 and Sep 20, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A LEFT HINDFOOT FUSION SURGERY THE JAW OF GRASPER BROKE IN-CASE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269348 ↗
• MalfunctionJun 18, 2024Break; Break

  ON 21 MAY 2024 IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-4160FT BONE REDUCTION FORCEPS W/TEETH BROKE DURING USE. THIS OCCURRED ON (B)(6) 2024 DURING A MID FOOT FUSION IN SOUTHERN CROSS HOSPITAL WELLINGTON. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE USE OF ANOTHER FORCEPS. THERE WAS CASE INVOLVEMENT

  Patient problems: Insufficient Information

  MAUDE report 19556551 ↗
• MalfunctionFeb 23, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-4160FT BONE REDUCTION FORCEPS BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427749 ↗