Arthrex® AR-3638DHSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867295551), received between Dec 6, 2023 and Apr 26, 2024 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionApr 26, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK INSERTER BROKE DURING IMPLANTATION. ADDITIONALLY, THE STRAIGHT DRILL GUIDE FROM AN AR-3638DHS DISPOSABLES KIT ALSO BROKE INSIDE THE PATIENT. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED; NOTHING FURTHER WAS IMPLANTED. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED AROUND FIFTEEN MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 19194025 ↗
• InjuryDec 6, 2023Break; Break

  ON (B)(3) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 3) OF AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHOR (FROM TWO DIFFERENT LOT NUMBERS) AND A (QTY. 2) OF AN AR-3638DHS DISPOSBALES KIT, FOR KNOTLESS HIP FIBERTAK SUTURE ANCHOR, STRAIGHT ANCHORS WERE BREAKING IN THE BONE WHEN REMOVING THE INSERTER. THE CASE WAS COMPLETED IN DEBRIDEMENT INSTEAD OF REPAIR, CAUSING A CASE DELAY OF 1 HOUR WITH ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT. ALL PIECES OF THE ANCHORS WERE REMOVED, AND THE CASE WAS NOT COMPLETED. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY LABRAL REPAIR PROCEDURE ON (B)(3) 2023.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18277562 ↗
• InjuryDec 6, 2023Break; Break

  ON 11/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 3) OF AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHOR (FROM TWO DIFFERENT LOT NUMBERS) AND A (QTY. 2) OF AN AR-3638DHS DISPOSBALES KIT, FOR KNOTLESS HIP FIBERTAK SUTURE ANCHOR, STRAIGHT ANCHORS WERE BREAKING IN THE BONE WHEN REMOVING THE INSERTER. THE CASE WAS COMPLETED IN DEBRIDEMENT INSTEAD OF REPAIR, CAUSING A CASE DELAY OF 1 HOUR WITH ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT. ALL PIECES OF THE ANCHORS WERE REMOVED, AND THE CASE WAS NOT COMPLETED. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY LABRAL REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 18277215 ↗