Arthrex® AR-3636-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00888867362857), received between May 1, 2023 and Sep 11, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732877 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716339 ↗
• MalfunctionJul 27, 2026Positioning Failure; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50018659 ↗
• MalfunctionMay 14, 2026Component Missing

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE IMPLANT CAME PRELOADED WITH TAPE AND SUTURES, BUT ONE LOOP WAS MISSING. THE PROCEDURE COULD BE COMPLETED; HOWEVER, THE SURGEON HAD TO TIE KNOTS EVEN THOUGH THE IMPLANT IS DESIGNED TO BE KNOTLESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 25173166 ↗
• MalfunctionMay 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE ANCHOR PULLED OUT BEFORE IT COULD BE FIXATED. 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 25084567 ↗
• MalfunctionMay 5, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE ANCHOR PULLED OUT BEFORE IT COULD BE FIXATED. 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 25084559 ↗
• MalfunctionApr 14, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE SUTURE OF THE DEVICE TORE. 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 24876491 ↗
• MalfunctionApr 9, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SUTURE OF THE DEVICE TORE DURING TIGHTENING. PER COMPLAINT REPORTER 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834598 ↗
• MalfunctionFeb 18, 2026Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SURGEON INSERTED THE IMPLANT, AND AFTER REMOVING THE INSERTER PART, IT TURNED OUT TO BE BROKEN. THE ANCHOR REMAINED TOGETHER WITH A PIECE OF METAL THAT STAYED IN THE BONE AND PROTRUDED FROM IT. DURING THE REMOVAL OF THIS METAL, THE SUTURES TORE, LEAVING A FABRIC ANCHOR IN THE BONE ALONG WITH TWO METAL PRONGS THAT COULD NOT BE REMOVED. 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: Foreign Body In Patient

  MAUDE report 24378034 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, THE SUTURE DETACHED FROM THE IMPLANT WHEN TENSION WAS APPLIED. 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 24268310 ↗
• MalfunctionJan 13, 2026Physical Resistance/Sticking

  ON 16TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3636-1, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 1, THE FIBERTAK SUTURE DID NOT RUN/REDUCE, THE KNOTLESS MECHANISM WAS FAULTY. THIS WAS DETECTED DURING USE IN A SHOULDER LABRAL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE IMPLANT WAS CUT OUT AND A SUBSEQUENT ANCHOR WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059007 ↗
• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ON 25TH NOVEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3636-1, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 1, THE ANCHOR DEPLOYED INTO THE GLENOID RIM, THE BLUE RETENTION SUTURE WAS SHUTTLED AROUND THE LABRAL, THIS WAS THEN THREADED INTO THE SHUTTLE SUTURE WHICH IS ATTACHED TO THE ANCHOR AND SHUTTLED THROUGH. THE SHUTTLE SUTURE HAD NO STOP POINT AND IT UNTHREADED ENTIRELY CAUSING THE ANCHOR TO FAIL. THIS WAS DETECTED DURING AN ARTHROSCOPIC LABRAL REPAIR - SHOULDER PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER FOUR ANCHORS WERE USED.

  Patient problems: Insufficient Information

  MAUDE report 23780465 ↗
• MalfunctionDec 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE LABRAL REPAIR THE ANCHOR TORN. 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. (B)(6) 2025 MAJUNG - FURTHER INFORMATION RECEIVED FROM ARTHREX CZ: THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769427 ↗
• MalfunctionDec 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE LABRAL REPAIR THE ANCHOR TORN. 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. 26-NOVEMBER-2025 MAJUNG - FURTHER INFORMATION RECEIVED FROM ARTHREX CZ: THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769295 ↗
• MalfunctionDec 1, 2025Break; Break

  ON 11 NOVEMBER 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3636-1, KL 1.8 FIBERTAK SHOULDER WAS REPORTED TO HAVE THE SUTURE SNAPPED DURING USE. THIS OCCURRED ON (B)(6) 2025 DURING AN ARTHROSCOPIC SHOULDER STABILISATION. IT WAS REPORT THAT THE INSERTED 1.8MM FIBERTAK ANCHOR PER TECHNIQUE FOR A SHOULDER STABILISATION - PASSED THE REPAIR STITCH UNDER THE LABRUM AND WENT TO SHUTTLE THE REPAIR SUTURE THROUGH THE KNOTLESS MECHANISM WITH THE WHITE/BLACK SHUTTLE SUTURE, BUT IT WOULD NOT SLIDE. THE REP HAD THE SURGEON USE AN ARTHROSCOPIC GRASPER TO TRY AND FREE THE SHUTTLE SUTURE CLOSE TO THE ANCHOR BODY BUT STILL IT WOULD NOT SLIDE. THE SURGEON ATTEMPTED TO PULL ON IT MUCH HARDER, BUT IT SNAPPED THE SHUTTLE SUTURE. THE CASE WAS COMPLETED SUCCESSFULLY BY A DRILLING THE ANCHOR OUT AND INSERTING ANOTHER ONE. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 23682245 ↗
• MalfunctionOct 23, 2025Break; Break

  ON 17TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-3636-1, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 1, THE ANCHORS BROKE DURING PASSING OF THE REPAIR SUTURE THROUGH THE KNOTLESS MECHANISM OF THE ANCHOR. THE LIMB OF THE SHUTTLING SUTURE BROKE OFF FROM THE LOOPED PORTION MEANING THE REPAIR SUTURE WAS UNABLE TO BE FULLY CONVERTED. THIS WAS DETECTED DURING USE IN A SHOULDER INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW KNOTLESS 1.8MM FIBERTAK ANCHOR WAS OPENED AND USED.

  Patient problems: Insufficient Information

  MAUDE report 23367299 ↗
• MalfunctionOct 23, 2025Failure to Advance; Failure to Advance

  ON 20TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3636-1, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 1, THE 1.8MM FIBERTAK KNOTLESS MECHANISM FAILED TO WORK AND THE SHUTTLING SUTURES DID NOT RUN INSIDE THE MECHANISM. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER ANCHOR WAS OPENED AND WORKED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366471 ↗
• MalfunctionOct 21, 2025Break; Break

  ON 17TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-3636-1, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 1, THE ANCHORS BROKE DURING PASSING OF THE REPAIR SUTURE THROUGH THE KNOTLESS MECHANISM OF THE ANCHOR. THE LIMB OF THE SHUTTLING SUTURE BROKE OFF FROM THE LOOPED PORTION MEANING THE REPAIR SUTURE WAS UNABLE TO BE FULLY CONVERTED. THIS WAS DETECTED DURING USE IN A SHOULDER INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW KNOTLESS 1.8MM FIBERTAK ANCHOR WAS OPENED AND USED.

  Patient problems: Insufficient Information

  MAUDE report 23346113 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LABRAL REPAIR SURGERY THE SUTURE OF THE ANCHOR TORE. 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 23294796 ↗
• MalfunctionSep 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AN UNKNOWN ISSUE WITH THE REPORTED DEVICE HAS OCCURRED DURING A KNEE SURGERY. 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 23089701 ↗
• MalfunctionSep 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR PULLED OUT OF THE PREDRILLED CHANNEL. 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 23064863 ↗
• MalfunctionSep 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AN UNKNOWN ISSUE WITH THE REPORTED DEVICE HAS OCCURRED DURING A KNEE SURGERY. 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 23008122 ↗
• MalfunctionAug 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE ANCHOR PULLED OUT OF THE PRE-DRILLED HOLE. 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 22839510 ↗
• MalfunctionAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGEY THE ANCHOR DISLODGED OUT OF THE PREDRILLED HOLE. 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 22736993 ↗
• MalfunctionAug 4, 2025Break; Break

  ON 23RD JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3636-1, KNOTLESS 1.8 FIBERTAK® SOFT ANCHOR, GEN2, WITH #2 SUTURE, QTY. 1, THE REPAIR SUTURE DID NOT SHUTTLE ENTIRELY THROUGH THE ANCHOR AND IT GOT STUCK HALFWAY THROUGH AND THE SUTURE BROKE OFF. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC STABILISATION/ LABRAL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE ANCHOR WAS RE-DRILLED AND A DIFFERENT ANCHOR WAS USED. (B)(6) 2025 - THE SUTURE BROKE AFTER IT GOT STUCK AS IT SHUTTLED BACK THROUGH ITSELF. THE END THAT WAS IN THE SURGEON'S HAND WAS DISCARDED. THE REMAINING SUTURE AND IMPLANT WAS RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706312 ↗