Arthrex® AR-3602-2-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867287112), received between Nov 16, 2021 and Jul 1, 2024 — classified as 3 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 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.

• MalfunctionJul 1, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR ALREADY HAD THIS RED REINFORCEMENT ON THE ANCHOR NECK, WHICH SHOULD NOT HAVE BEEN THERE. THE CUSTOMER WORKS WITH THE SPEAR AR-1948, BUT THIS IS NOT INTENDED FOR THIS NEW FIBERTAK WITH THE REINFORCEMENT ON THE ANCHOR NECK. THIS NEW ANCHOR DOES NOT FIT INTO THE SPEAR AR-1948, SO THE ANCHOR COULD NOT BE USED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT 24-JUN-2024: ANOTHER FIBERTAK WAS USED TO FINISH THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647816 ↗
• MalfunctionApr 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY AFTER INSERTING THE ANCHOR INTO THE PREPARED CHANNEL, THE END OF THE GUIDEWIRE FRACTURED WHICH ALSO RESULTED IN THE RUPTURE OF SUTURES. THE BROKEN PARTS WERE RETRIEVED FROM PATIENT AND A NEW DEVICE WITH THE SAME PART NUMBER WAS USED TO FINISH THE SURGERY SUCCESSFULLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112178 ↗
• MalfunctionNov 16, 2021Break

  IT WAS REPORTED THAT DURING THE TREATMENT OF A SHOULDER INSTABILITY A PART OF THE ANCHOR BROKE OFF INSIDE THE PATIENT. THE SURGEON DECIDED TO LET THE DEVICE AT THE PLACE AS HE DIDN´T WANT TO DRILL THE CARTILAGE TO RETRIEVE THE BROKEN FRAGMENT. THE CUSTOMER DECIDED TO RECEIVE A REVISION SURGERY IN ANOTHER HOSPITAL TO RETRIEVE THE PART. 29-OCT-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE TIP OF THE ANCHOR OVER WHICH THE THREAD IS TENSIONED BROKE OFF. THE DRILL SLEEVE WAS NOT AFFECTED IN THIS CONTEXT. THE SURGEON USED THE 2-LOAD FIBERTAK WITH SUTURETAPE. HE PLACED 2 ANCHORS AND THE PROBLEM HAPPENED WITH THE THIRD ONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12819020 ↗