Arthrex® AR-3636Recalls & reported problems

Summary

The FDA's MAUDE database contains 624 adverse event reports that list this exact device (DI 00888867362871), received between Sep 6, 2022 and Sep 23, 2026 — classified as 25 injuries, 599 malfunctions.

The most frequently reported specific device problem is “Break” (271 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 624 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that during the shoulder stabilization surgery, the repair suture of two AR-3636 snapped after they had been placed using the placement instrument AR-3610CTC. As a result, the placement instrument AR-3610CTC was replaced, and the remaining new AR-3636 implants were successfully placed. 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 50869074 ↗
• MalfunctionSep 23, 2026Break

  It was reported that during the shoulder stabilization surgery, the repair suture of two AR-3636 snapped after they had been placed using the placement instrument AR-3610CTC. As a result, the placement instrument AR-3610CTC was replaced, and the remaining new AR-3636 implants were successfully placed. 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 50868949 ↗
• MalfunctionSep 16, 2026Break

  On (b)(6) 2026, it was reported by an Arthrex employee via email that for an AR-3636, Knotless 1.8 FiberTak® soft anchor, Gen2, with #2 suture, qty. 5, while relaying the repair suture to the labrum, the suture snapped at a point approximately two-thirds of the way along its length. This was detected during use in a labrum repair procedure on (b)(6) 2026. The procedure was completed successfully, the suture was used as-is, and the repair was successfully completed without the other issues.No significant surgery delay reported. No additional anesthesia administered to the patient. No information about an instrument used to prepare/tap the bone socket for insertion of the implant. Bone quality of the patient is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50789538 ↗
• MalfunctionSep 16, 2026Positioning Failure

  Patient problems: Insufficient Information

  MAUDE report 50788263 ↗
• MalfunctionSep 15, 2026Physical Resistance/Sticking

  It was reported that during a shoulder arthroscopy the knotless mechanism was faulty and could not be tightened. 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 50775965 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570544 ↗
• MalfunctionAug 31, 2026Material Split, Cut or Torn

  It was reported that during an arthroscopic labrum surgery the suture tore after it could not be adequately tightened. 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 50518758 ↗
• MalfunctionJul 31, 2026Device Dislodged or Dislocated; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099674 ↗
• MalfunctionJul 29, 2026Physical Resistance/Sticking

  On 13-Jul-2026, a sales representative reported via email that two AR-3636 Knotless 1.8 FiberTak Soft Anchor devices failed to function as intended during a labral repair procedure performed on 06-Jul-2026. During deployment, the knotless mechanisms converted and locked, preventing the repair stitches from being fully tensioned. The knotless loops could not be adequately tightened before becoming stuck. The issue occurred with two devices from the same lot. The surgeon switched to devices from a different lot and completed the procedure. The procedure was prolonged by approximately 30 minutes. There was no patient harm reported.Additional information was received on 17-Jul-2026:Both AR-3636 anchors were successfully implanted before the issue occurred. The knotless mechanisms became stuck during the tensioning phase of the procedure. No visible abnormalities, including fraying, tangling, or damage to the sutures or knotless mechanisms, were observed.The surgeon applied increased force while attempting to tension the repair stitches, at which point the stitch broke. The anchor remained fixed within the bone, requiring the surgeon to drill over the implanted anchor and place a replac

  Patient problems: Foreign Body In Patient

  MAUDE report 50071765 ↗
• MalfunctionJul 29, 2026Physical Resistance/Sticking

  Patient problems: Foreign Body In Patient

  MAUDE report 50071698 ↗
• MalfunctionJul 27, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50019332 ↗
• MalfunctionJun 30, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A LABRUM REPAIR SURGERY THE CONVERSION MECHANISM OF A 1.8 KNOTLESS FIBERTAK DID NOT WORK ON THREE DIFFERENT OCCASIONS INTRAOPERATIVELY. THE SURGEON TRIED TO UPLIFT 10 TIMES. 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 23-JUN-26: MORE INFORMATION WAS PROVIDED THAT CLARIFIES THE FAILURE MECHANISM: IN TERMS OF THE ISSUE, ANCHORS WENT IN AND HELD FINE. AS WE WERE TRYING TO CONVERT THE FIXED BLUE SUTURE THE SHUTTLE STITCH WOULD CONVERT THROUGH THE ANCHOR HOWEVER WOULDN'T BRING THE REPAIR SUTURE THROUGH THE MECHANISM TO CREATE THE MATTRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663766 ↗
• MalfunctionApr 29, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE FIBERTAK WOULDN'T ANCHOR PROPERLY. 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 25034891 ↗
• MalfunctionApr 10, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A IN MENISCUS TRANSPLANTATION AS MENISCUS CENTRALIZATION SURGERY THE SHUTTLE SUTURE COULD BE SHUTTLED THROUGH THE ANCHOR, BUT THE BLUE REPAIR THREAD WOULDN'T CLOSE THE LOOP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24839301 ↗
• MalfunctionMar 13, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGERY THE SUTURE OF THE DEVICE TORE AT THE TRANSITION TO THE REPAIR SUTURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588911 ↗
• MalfunctionMar 11, 2026Break; Material Split, Cut or Torn

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3636, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 5, THE SURGEON PASSED THE WORKING SUTURE THROUGH THE PASSING SUTURE AND GOT IT THROUGH THE ANCHOR. WHEN HE WAS TIGHTENING THE WORKING SUTURE TO BRING THE LABRUM TO THE GLENOID, THE SUTURE SNAPPED AND HE WAS UNABLE TO TIGHTEN IT FURTHER. THE LABRUM WAS NOT SECURED AGAINST BONE, AND SURGEON WAS UNABLE TO REMOVE THE ANCHOR. THIS WAS DETECTED DURING A SHOULDER LABRUM REPAIR PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON USED ANOTHER 1.8 MM FIBERTAK ANCHOR.

  Patient problems: Foreign Body In Patient

  MAUDE report 24574206 ↗
• MalfunctionMar 10, 2026Positioning Failure

  ON 17-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-3636 FIBERTAK SUTURES WOULD NOT SHUTTLE CORRECTLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THERE WAS A 10-MINUTE DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556666 ↗
• MalfunctionMar 10, 2026Positioning Failure

  ON 17-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-3636 FIBERTAK SUTURES WOULD NOT SHUTTLE CORRECTLY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THERE WAS A 10-MINUTE DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556533 ↗
• MalfunctionMar 6, 2026Break

  ON 13-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3636 FIBERTAK IMPLANT REPAIR SUTURE WAS FRAYED AND THE SUTURE BROKE ON TENSIONING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO THE CASE. THE CASE WAS COMPLETED USING THE ANOTHER FIBERTAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530922 ↗
• MalfunctionMar 5, 2026Break

  ON 12-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHOR WAS DIFFICULT TO TENSION. DURING TENSIONING OF THE BLUE #2 FIBERWIRE AROUND THE LABRUM, THE SUTURE WAS VERY HARD TO PULL AND ULTIMATELY BROKE MIDWAY ALONG ITS LENGTH. DESPITE THE BREAKAGE, THERE WAS SUFFICIENT REMAINING SUTURE TO FULLY TENSION THE ANCHOR, ALTHOUGH THE SURGEON HAD TO APPLY FORCE. THE SUTURE DID NOT BECOME BOUND UP. THE CASE WAS COMPLETED WITH ALL THREE INITIAL ANCHORS LEFT IMPLANTED IN THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-FEB-2026: DURING A SLAP REPAIR PROCEDURE, ALL BROKEN SUTURE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SUTURES WERE ULTIMATELY CUT AT THE LABRUM AS PART OF THE STANDARD TECHNIQUE. THE THREE INITIAL ANCHORS REMAINED IMPLANTED AND WERE USED TO COMPLETE THE REPAIR. ALL ANCHORS WERE SEATED IN BONE; HOWEVER, ONE ANCHOR DID NOT FULLY TIGHTEN AND REMAINED SLIGHTLY LOOSE AROUND THE SIMPLE STITCH, THOUGH THE SURGEON DEEMED THE FIXATION ACCEPTABLE. ALL ANCHORS WERE INTACT WHEN FULLY SEATED. INFORMATION REGARDING CASE DELAY OR THE ADMINISTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519296 ↗
• MalfunctionMar 5, 2026Break

  ON 12-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHOR WAS DIFFICULT TO TENSION. DURING TENSIONING OF THE BLUE #2 FIBERWIRE AROUND THE LABRUM, THE SUTURE WAS VERY HARD TO PULL AND ULTIMATELY BROKE MIDWAY ALONG ITS LENGTH. DESPITE THE BREAKAGE, THERE WAS SUFFICIENT REMAINING SUTURE TO FULLY TENSION THE ANCHOR, ALTHOUGH THE SURGEON HAD TO APPLY FORCE. THE SUTURE DID NOT BECOME BOUND UP. THE CASE WAS COMPLETED WITH ALL THREE INITIAL ANCHORS LEFT IMPLANTED IN THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-FEB-2026: DURING A SLAP REPAIR PROCEDURE, ALL BROKEN SUTURE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SUTURES WERE ULTIMATELY CUT AT THE LABRUM AS PART OF THE STANDARD TECHNIQUE. THE THREE INITIAL ANCHORS REMAINED IMPLANTED AND WERE USED TO COMPLETE THE REPAIR. ALL ANCHORS WERE SEATED IN BONE; HOWEVER, ONE ANCHOR DID NOT FULLY TIGHTEN AND REMAINED SLIGHTLY LOOSE AROUND THE SIMPLE STITCH, THOUGH THE SURGEON DEEMED THE FIXATION ACCEPTABLE. ALL ANCHORS WERE INTACT WHEN FULLY SEATED. INFORMATION REGARDING CASE DELAY OR THE ADMINISTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519293 ↗
• MalfunctionMar 5, 2026Break

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHOR WAS DIFFICULT TO TENSION. DURING TENSIONING OF THE BLUE #2 FIBERWIRE AROUND THE LABRUM, THE SUTURE WAS VERY HARD TO PULL AND ULTIMATELY BROKE MIDWAY ALONG ITS LENGTH. DESPITE THE BREAKAGE, THERE WAS SUFFICIENT REMAINING SUTURE TO FULLY TENSION THE ANCHOR, ALTHOUGH THE SURGEON HAD TO APPLY FORCE. THE SUTURE DID NOT BECOME BOUND UP. THE CASE WAS COMPLETED WITH ALL THREE INITIAL ANCHORS LEFT IMPLANTED IN THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 25-FEB-2026: DURING A SLAP REPAIR PROCEDURE, ALL BROKEN SUTURE FRAGMENTS WERE REMOVED FROM THE PATIENT. THE SUTURES WERE ULTIMATELY CUT AT THE LABRUM AS PART OF THE STANDARD TECHNIQUE. THE THREE INITIAL ANCHORS REMAINED IMPLANTED AND WERE USED TO COMPLETE THE REPAIR. ALL ANCHORS WERE SEATED IN BONE; HOWEVER, ONE ANCHOR DID NOT FULLY TIGHTEN AND REMAINED SLIGHTLY LOOSE AROUND THE SIMPLE STITCH, THOUGH THE SURGEON DEEMED THE FIXATION ACCEPTABLE. ALL ANCHORS WERE INTACT WHEN FULLY SEATED. INFORMATION REGARDING CASE DELAY OR THE ADMINISTR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519291 ↗
• MalfunctionMar 3, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE SUTURE OF THE DEVICE DID NOT SHUTTLE. 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 24495170 ↗
• MalfunctionFeb 27, 2026Material Twisted/Bent

  ON 11TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-3636, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 5, THE SURGEON ENCOUNTERED AN ISSUE WHERE A KNOT WAS FORMED ON THE REPAIR SUTURE WHILE ADVANCING IT INTO THE BONE WHICH PREVENTED PROPER TENSIONING. THIS WAS DETECTED DURING A (B)(6) ON 10TH FEB 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING A NEW AR-3636.

  Patient problems: Insufficient Information

  MAUDE report 24471865 ↗
• MalfunctionFeb 24, 2026Physical Resistance/Sticking

  ON 06-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHOR EXPERIENCED AN ISSUE DURING A SHOULDER LABRAL REPAIR PROCEDURE. AFTER THE ANCHOR WAS INSERTED IN THE STANDARD MANNER AND THE REPAIR STITCH WAS SHUTTLED AROUND THE LABRUM, THE SHUTTLE SUTURE WAS REMOVED. WHEN ATTEMPTING TO TENSION THE REPAIR SUTURE, THE SUTURE BECAME LOCKED WITHIN THE ANCHOR AND COULD NOT BE FULLY CINCHED. THE SURGEON ATTEMPTED TO PULL THE SUTURE IN THE REVERSE DIRECTION TO FREE THE MECHANISM; HOWEVER, THE SUTURE REMAINED LOCKED IN BOTH DIRECTIONS. THE REPAIR SUTURE WAS SUBSEQUENTLY CUT, LEAVING THE ANCHOR BODY IN PLACE, AND AN ADDITIONAL KNOTLESS FIBERTAK ANCHOR WAS PLACED TO COMPLETE THE REPAIR. THE EVENT OCCURRED INTRAOPERATIVELY ON 06-FEB-2026 WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 13-FEB-2026: THE CASE WAS DELAYED BY LESS THAN 5 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED DUE TO THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24431949 ↗