Arthrex® AR-3602-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867287099), received between Sep 20, 2023 and Jul 30, 2025 — classified as 1 injury, 5 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING THE SUPERIOR LABRAL ANTERIOR POSTERIOR SURGERY THAT THE ANCHOR DISLOCATED FROM THE BONE. 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 22663269 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURE BROKE WHILE TIGHTENING THE LOOP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395955 ↗
• MalfunctionJul 24, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A BICEPS TENDON SURGERY THE ANCHOR DID NOT HOLD IN PLACE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816510 ↗
• MalfunctionMay 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE ANCHOR TORN OUT DURING SEWING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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. UPDATE SWIT 14-APR-2022: WHEN TIGHTENING THE ANCHOR "TORE OUT", AS IT COULD NOT BE PULLED TIGHT AND CAME OUT LOOSE AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391946 ↗
• InjuryMar 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A HIP SURGERY THE DRIVER OF THE DEVICE BROKE OFF. THIS ISSUE WAS NOTICED ON THE X-RAY PICTURE AFTER THE SURGERY WAS FINISHED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18835600 ↗
• MalfunctionSep 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY GLENOID RECONSTRUCTION SURGERY AFTER INSERTING THE ANCHOR INTO THE PREPARED CHANNEL, THE END OF THE GUIDEWIRE FRACTURED INSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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. UPDATE (B)(6) 2023 NROE: THE BROKEN PIECES WERE RETRIEVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17782872 ↗