Arthrex® AR-3633Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867276925), received between Mar 29, 2018 and Jun 7, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 9/8/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3633 FIBERTAK¿ RC SUTURE ANCHOR, TRIPLE LOADED WOULD NOT SEAT IN THE PRE-DRILLED BONE TUNNEL. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. NO PATIENT AFFECTED. DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY FACILITY. ADDITIONAL INFO RECEIVED 9/15/2021 SURGEON COMPLETED ROTATOR CUFF MASSIVE TEAR REPAIR BY USING ANOTHER AR-3633 ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483214 ↗
• MalfunctionMay 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3633 FIBERTAK SUTURE ANCHOR PULLED OUT. SURGEON RELOADED THE ANCHOR AND ATTEMPTED TO IMPLANT IT TWO MORE TIMES, EACH TIME THE ANCHOR CONTINUED TO PULL OUT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED BY REMOVING EVERYTHING FROM INSIDE THE PATIENT AND OPENING AN AR-2324PSLC-2 PEEK SWIVELOCK.

  Patient problems: Insufficient Information

  MAUDE report 19350411 ↗
• MalfunctionJun 7, 2021Break

  IT WAS REPORTED THAT DURING A PECTORALIS REFIX SURGERY WHILE INSERTING THE IMPLANT THE DRIVER OF THE IMPLANT DISSECTED THE THREAD. FURTHER IT WAS REPORTED THAT THE TIP BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE PART OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 11947876 ↗
• InjuryMar 29, 2018Entrapment of Device; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT DURING A PROXIMAL TENODESIS PROCEDURE THE SURGEON WAS USING THE IMPLANT AND DRILLED FOR IT AND UPON INSERTING THE IMPLANT IT PULLED OUT. IN THE ATTEMPT TO REMOVE THE INSERTER; THE ANCHOR CAME OUT WITH THE DRIVER AND ONE OF THE PRONGS WAS LEFT BEHIND IN THE JOINT. SURGEON DID NOT TAKE X-RAYS AND WASHED THE AREA OUT. IT IS UNKNOWN IF THE PIECE WAS RETRIEVED FROM THE PATIENT. X-RAYS WERE NOT TAKEN AND THE SURGEON WAS NOT TOO CONCERNED. OPENED ANOTHER FIBERTAK AND COMPLETED THE PROCEDURE. PATIENT: MALE IN HIS 30'S. FOLLOW-UP INVESTIGATION: THE IMPLANT ITSELF DID NOT PULL OUT ON IT'S OWN. THE IMPLANT PULLED OUT BECAUSE IT WAS ATTACHED TO THE DRIVER AND WHEN THE DRIVER WAS BEING REMOVED THE IMPLANT CAME WITH IT. THE PRONG THAT REMAINED IN THE PATIENT WAS FROM THE INSERTER DEVICE, NOT THE IMPLANT ITSELF. THE FIBERTAK THAT WAS USED TO COMPLETE THE PROCEDURE WAS PLACED IN THE SAME DRILL HOLE AS THE ANCHOR THAT PULLED OUT WITH THE DRIVER. THE AR-3633 ANCHOR AND THE INSERTER DEVICE THAT COMES WITH THE ANCHOR ARE BOTH BEING RETURNED TO ARTHREX FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7380862 ↗