Arthrex® AR-4068-90HRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867031524), received between Jul 28, 2023 and Aug 4, 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 18, 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.

• MalfunctionAug 4, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-4068-90H SUTURELASSO'S WIRE AT THE TIP BROKE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17464776 ↗
• MalfunctionJul 28, 2023Break; Break

  07/12/2023, RECEIVED RESPONSE WITH ADDITIONAL INFORMATION: WHAT TYPE OF CASE DID THIS OCCUR IN? - HIP SCOPE. HOW DID THE DEVICE BREAK? - WIRE LASSO BROKE WHILE SURGEON WAS PULLING IT THROUGH JOINT. HOW WAS THE CASE COMPLETED? - USED THE SAME PRODUCT WITH A NEW LOT NUMBER. WAS THERE ANY EFFECT ON THE PATIENT? - NO.

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

  MAUDE report 17417408 ↗