Arthrex® AR-3600Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00888867101890), received between May 17, 2018 and Sep 17, 2026 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805592 ↗
• MalfunctionSep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805252 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: Insufficient Information

  MAUDE report 50563331 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50430805 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50430667 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50430338 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50430017 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50429345 ↗
• MalfunctionFeb 23, 2026Device Dislodged or Dislocated

  ON 05-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3600 FIBERTAK SUTURE 1.6 MM ANCHOR PULLED OUT WHILE CHECKING FIXATION. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-3600 FIBERTAK SUTURE 1.6 MM ANCHOR. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND NOTHING REMAINED IN THE PATIENT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE RELATED TO THIS ISSUE. THE ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416545 ↗
• MalfunctionDec 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3600 FIBERTAK ANCHOR CAME OUT OF THE HOLE DRILLED FOR ITS INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO REPORTED PATIENT HARM. THE CASE WAS COMPLETED USING A SUTURETAK ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743918 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE AR-3600 DID NOT FIT THROUGH AIMER AR-3610CTC, AS THE RED STABILISER PEG GOT STUCK. 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. UPDATE AVOE 27-OCT-2025: IT WAS CONFIRMED THAT WHEN THE SURGEON USED THE DEVICE AR-3600 IN THE AR-3610CTC SPEAR, THE STABILIZATION PEG OF THE AR-3600 GOT STUCK AND BROKE INSIDE THE SPEAR WHEN THE DEVICE WAS REMOVED WITH FORCE FROM THE SPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427326 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE AR-3600 DID NOT FIT THROUGH AIMER AR-3610CTC, AS THE RED STABILISER PEG GOT STUCK. 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. UPDATE AVOE 27-OCT-2025 IT WAS CONFIRMED THAT WHEN THE SURGEON USED THE DEVICE AR-3600 IN THE AR-3610CTC SPEAR, THE STABILIZATION PEG OF THE AR-3600 GOT STUCK AND BROKE INSIDE THE SPEAR WHEN THE DEVICE WAS REMOVED WITH FORCE FROM THE SPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427248 ↗
• MalfunctionOct 30, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE AR-3600 DID NOT FIT THROUGH AIMER AR-3610CTC, AS THE RED STABILISER PEG GOT STUCK. 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. UPDATE AVOE 27-OCT-2025. IT WAS CONFIRMED THAT WHEN THE SURGEON USED THE DEVICE AR-3600 IN THE AR-3610CTC SPEAR, THE STABILIZATION PEG OF THE AR-3600 GOT STUCK AND BROKE INSIDE THE SPEAR WHEN THE DEVICE WAS REMOVED WITH FORCE FROM THE SPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427107 ↗
• MalfunctionOct 30, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE AR-3600 DID NOT FIT THROUGH AIMER AR-3610CTC, AS THE RED STABILISER PEG GOT STUCK. 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. UPDATE (B)(6) 27-OCT-2025: IT WAS CONFIRMED THAT WHEN THE SURGEON USED THE DEVICE AR-3600 IN THE AR-3610CTC SPEAR, THE STABILIZATION PEG OF THE AR-3600 GOT STUCK AND BROKE INSIDE THE SPEAR WHEN THE DEVICE WAS REMOVED WITH FORCE FROM THE SPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426949 ↗
• MalfunctionOct 30, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE AR-3600 DID NOT FIT THROUGH AIMER AR-3610CTC, AS THE RED STABILISER PEG GOT STUCK. 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. UPDATE AVOE 27-OCT-2025: IT WAS CONFIRMED THAT WHEN THE SURGEON USED THE DEVICE AR-3600 IN THE AR-3610CTC SPEAR, THE STABILIZATION PEG OF THE AR-3600 GOT STUCK AND BROKE INSIDE THE SPEAR WHEN THE DEVICE WAS REMOVED WITH FORCE FROM THE SPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426767 ↗
• MalfunctionOct 30, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A BANKART REPAIR SURGERY THE AR-3600 DID NOT FIT THROUGH AIMER AR-3610CTC, AS THE RED STABILISER PEG GOT STUCK. 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. UPDATE AVOE 27-OCT-2025 IT WAS CONFIRMED THAT WHEN THE SURGEON USED THE DEVICE AR-3600 IN THE AR-3610CTC SPEAR, THE STABILIZATION PEG OF THE AR-3600 GOT STUCK AND BROKE INSIDE THE SPEAR WHEN THE DEVICE WAS REMOVED WITH FORCE FROM THE SPEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426668 ↗
• MalfunctionSep 18, 2025Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn

  ON 08/30/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3600 FIBERTAK SUTURE ANCHOR EXPERIENCED AN ISSUE. AFTER THE ANCHOR WAS PLACED FOLLOWING THE CORRECT STEPS, A GENTLE PULL WAS PERFORMED TO VERIFY PLACEMENT. AS A RESULT, THE ANCHOR CAME OUT. UPON INSPECTION, IT WAS FOUND TO BE TORN (SEE PHOTO ATTACHMENT). THE CASE WAS COMPLETED; HOWEVER, NO SPECIFIC DETAILS WERE PROVIDED REGARDING HOW IT WAS FINALIZED. THIS ISSUE WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE PERFORMED ON (B)(6)2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 09/08/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086108 ↗
• MalfunctionSep 2, 2025Positioning Failure; Positioning Failure

  ON 08/13/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3600 FIBERTAK SUTURE ANCHOR FAILED TO SECURE UPON INSERTION. A SECOND ATTEMPT WAS MADE, BUT THE TIP OF THE ANCHOR WAS DAMAGED AND COULD NOT BE USED, WHICH LED TO ITS REMOVAL FROM THE PATIENT. THE CASE WAS COMPLETED USING A REPLACEMENT AR-3600 FIBERTAK SUTURE ANCHOR. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE. THE ISSUE WAS DISCOVERED DURING A PROCEDURE PERFORMED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945933 ↗
• MalfunctionMar 4, 2025Material Frayed; Material Frayed

  ON 02/17/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-3600 FIBERTAK SUTURE ANCHOR HAD A FRAYED SUTURE THREAD AFTER IT WAS PLACED IN THE BONE HOLE. THE SURGEON WAS CONCERNED ABOUT THE FIXATION AND REMOVED THE ANCHOR. A NEW BONE HOLE WAS DRILLED, AND A NEW AR-3600 FIBERTAK SUTURE ANCHOR WAS USED TO COMPLETE THE SURGERY. THIS WAS DISCOVERED DURING A SHOULDER DISLOCATION REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517597 ↗
• MalfunctionFeb 12, 2025Fitting Problem; Physical Resistance/Sticking; Fitting Problem; Physical Resistance/Sticking

  ON 01/27/2025, IT WAS REPORTED BY A ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(6) THAT AN AR-3610CTC-2 FIBNERTAK SPEAR AND AN AR-3600 FIBERTAK ANCHOR BECAME STUCK IN THE DRILL GUIDE WHEN THE SURGEON WENT TO INSERT. THIS OCCURRED DURING USE IN AN ARCR CASE WITH NO PATIENT HARM. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363336 ↗
• MalfunctionOct 10, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A LABRUM STABILIZATION SURGERY THE ANCHORS AR-3600 (LOT: 15232907 & 15246457) DID NOT FIT THROUGH THE DRILL SLEEVE AR-3610CTC. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415875 ↗
• MalfunctionOct 10, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A LABRUM STABILIZATION SURGERY THE ANCHORS AR-3600 (LOT: 15232907 & 15246457) DID NOT FIT THROUGH THE DRILL SLEEVE AR-3610CTC. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415806 ↗
• MalfunctionOct 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 09/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3600 FIBERTAK¿ SUTURE ANCHOR FAILED AND PULLED OUT. THIS OCCURRED DURING A SHOULDER SCOPE/LABRAL REPAIR WHEN THE FIBERTAK ANCHOR FAILED AND PULLED OUT. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343852 ↗
• MalfunctionJun 2, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE ANCHOR DID NOT FIT THROUGH THE ASSOCIATED SPEAR. 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 24-AUG-2022: A SPEAR WITH PART NUMBER AR-2948CT, LOT. 10122774 WAS USED. THE FOLLOWING ANCHORS DID FIT THROUGH THE SPEAR. THE NURSE SAID THAT ACCORDING TO HER FEELING, THE ANCHOR IS LOADED DIFFERENTLY. THAT IS, THE ANCHOR ITSELF IS PROBABLY A BIT CROOKED ON THE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444622 ↗
• MalfunctionApr 29, 2024Use of Device Problem; Use of Device Problem

  ON 03/29/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-3600 FIBERTAK SUTURES WERE LOOSEN AFTER INSERTING IT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19202667 ↗