Arthrex® AR-3602HRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867295520), received between May 28, 2020 and May 9, 2024 — classified as 3 injuries, 2 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 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/16/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THREE AR-3602H ANCHORS PULLED OUT OF THE BONE DURING A HIP ARTHROSCOPY. THE FIRST ONE PULLED OUT OF THE BONE WHEN IT WAS SET. IT WAS REPLACED AND THE SAME EVENT OCCURRED. A THIRD ANCHOR WAS USED BUT ONCE AGAIN PULLED OUT. THE ANCHORS WERE REPLACED WITH A NON ARTHREX PRODUCTS AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE CASE INVOLVED A 32 YEAR OLD FEMALE. TO DATE, SHE IS FINE. THE REP IS ALSO RETURNING THE AR-3600ND-2H DRILL BIT TO BE INSPECTED ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277616 ↗
• MalfunctionJun 6, 2022Break

  ON 5/19/2022, IT WAS REPORTED BY A SALE REPRESENTATIVE VIA EMAIL THAT AN AR-3602H HIP FIBERTAK SUTURE ANCHOR INSERTER BROKE. THE ANCHOR WAS SUCCESSFULLY IMPLANTED AND ALL BROKEN FRAGMENTS RETRIEVED. THIS WAS DISCOVERED DURING AN HIP ACETABULUM REPAIR ON (B)(6) 2022

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602964 ↗
• InjurySep 21, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A (B)(6) 2020 HIP ARTHROSCOPY/LABRAL REPAIR PROCEDURE FOUR AR-3602H, HIP FIBERTAK SUTURE ANCHORS (LOT 10298673), WERE USED. ONE OF THE INSERTER TIPS (APPROXIMATELY 1.5 - 2 CM) BROKE OFF AND WAS EMBEDDED IN THE PATIENT'S BONE. FRAGMENT WAS UNABLE TO BE RETRIEVED. SALES REPRESENTATIVE WHO WAS PRESENT REPORTS THE SURGEON DID NOT USE EXCESSIVE FORCE TO IMPLANT THE DEVICE AND FOLLOWED THE INSTRUCTIONS FROM THE TECHNIQUE GUIDE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10562574 ↗
• InjurySep 10, 2020Break

  IT WAS REPORTED THAT ONE OF THE METAL FORK TIPS ON THE INSERTER BROKE OFF DURING IMPLANT. THEY COULD NOT LOCATE THE TIP WITH X-RAY. THE CASE WAS A HIP LABRAL REPAIR.

  Patient problems: Foreign Body In Patient

  MAUDE report 10517109 ↗
• InjuryMay 28, 2020Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A HIP LABRAL REPAIR PROCEDURE, WHEN THE SURGEON WAS IMPACTING THE AR-3602H, THE ANCHOR BENT. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. DURING THE FOLLOWUP VISIT IT WAS FOUND THAT A PIECE OF THE IMPACTOR HAD BROKEN OFF. ADDITIONAL INFORMATION OBTAINED 5/5/2020: DURING THE FOLLOW UP VISIT AN X-RAY WAS TAKEN AND THE METALLIC FRAGMENT WAS VISUALIZED ON X-RAY. THE SURGEON DOES NOT HAVE PLANS FOR A SECOND SURGERY. THE IMPACTOR WAS EXAMINED AFTER THE SURGERY HOWEVER IT WAS NOT SUSPECTED THAT ANYTHING HAD BROKEN OFF AT THE TIME OF PROCEDURE AND THEREFORE IT WAS NOT EXAMINED THOROUGHLY FOR BREAKAGE. THE ANCHOR WAS TAKEN FROM FACILITY INVENTORY. ADDITIONAL INFORMATION OBTAINED 5/7/2020: THE BENT ANCHOR WAS LEFT IN THE PATIENT AND WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10096488 ↗