Arthrex® AR-3600-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867284814), received between Nov 26, 2019 and Sep 9, 2026 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Device Dislodged or Dislocated

  It was reported that during a labrum refixation surgery the anchor backed out. 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 50691089 ↗
• MalfunctionJan 14, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGERY THE IMPLANT WAS INCOMPATIBLE WITH THE INSTRUMENT AND THEREFORE NOT POSSIBLE TO USE. 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 21149104 ↗
• MalfunctionJan 14, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SURGERY THE IMPLANT WAS INCOMPATIBLE WITH THE INSTRUMENT AND THEREFORE NOT POSSIBLE TO USE. 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 21149049 ↗
• MalfunctionNov 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC GLENOID RECONSTRUCTION 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 DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20619846 ↗
• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC GLENOID SURGERY THE GUIDEWIRE OF THE DEVICE FRACTURED DURING IMPLANT INSERTION. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 AVOE 20-AUG-2024: IT WAS CONFIRMED THAT THE DRIVER/INSERTER OF THE DEVICE BROKE AND ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140778 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE THREADS BROKE AT THE LEVEL OF THE ANCHOR AFTER INSERTION INTO THE DEVICE WHILE TIGHTENING. THE BROKEN PIECES WERE RETRIEVED FROM 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.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16837630 ↗
• InjuryNov 26, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ARTHREX FIBERTAK AR-3600-1 WAS USED FOR A SHOULDER STABILIZATION. THE TIP OF THE DEVICE BROKE OFF INSIDE THE ANCHOR. THE ANCHOR WAS STILL CORRECTLY INSERTED AND FIXED. THE SURGEON THOUGHT HE HAD COMPLETELY REMOVED THE BROKEN TIP. AFTER THE SURGERY IT WAS FOUND THAT THE TIP BROKE INTO TWO PARTS AND ONLY ONE PART OF IT WAS REMOVED. FOR THIS REASON THE PATIENT HAD TO BE RE-SURGERIED ONE DAY LATER ON THE (B)(6) 2019. THE SECOND PART OF THE BROKEN OFF TIP WAS SUCCESSFULLY REMOVED WITH THE HELP OF THE RADIOGRAPH. NOTHING REMAINS IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376476 ↗