Arthrex® AR-3632Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867276901), received between Oct 24, 2022 and Sep 21, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Device Dislodged or Dislocated

  On (b)(6) 2026, it was reported by a Distributor via an Email that for 1 unit of AR-1588TN and 1 unit of AR-3632:The AR-1588TN broke during loop shortening steps on the tendon site while the AR-3632 was pulled out while fixing the ALL.This was detected during an ACL+ALL reconstruction procedure on (b)(6) 2026. The procedure was completed successfully by using additional AR-1588TN and AR-3632. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841872 ↗
• MalfunctionDec 1, 2025Break; Break

  ON 11TH NOV 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA AN EMAIL THAT FOR 1 UNIT OF AR-3632, FIBERTAK® SUTURE ANCHOR, 2.6 MM, DOUBLE LOADED, WITH 1.3 MM SUTURETAPE(WHITE / BLUE, WHITE / BLACK), THE FIBERTAK INNER SHAFT WAS BROKEN WHILE INSERTING THE ANCHOR INTO CLAVICLE FOR AC REPAIR. NO FRAGMENT OF BROKEN IMPLANT WAS LEFT INSIDE THE PATIENT. THIS WAS DETECTED DURING AN AC REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ADDITIONAL FIBERTAK. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION: THE DRILL STEP WAS PERFORMED REPEATEDLY TO LIMIT THE BONE FRAGMENT INSIDE THE HOLE BUT THE BROKEN ISSUE STILL OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682436 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE TIP OF THE DEVICE BROKE DURING INSERTION OF THE ANCHOR. THE ANCHOR COULD BE PLACED IN THE PATIENT. THE TIP REMAINED IN THE PATIENT. 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 21325249 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY 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 21322969 ↗
• MalfunctionJun 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SUTURE TAPE DOESN`T SLIDE PROPERLY IN THE DEVICE. IF THE INNER THREAD IS KNOTTED, THE OUTER THREAD WILL ALSO SLIDE, BUT IF THE OUTER THREAD IS KNOTTED FIRST, THE INNER THREAD NO LONGER SLIDES. FOR THE PATIENT THE OUTER THREAD COULD NO LONGER BE KNOTTED ALTHOUGH THE INNER THREAD (BLACK) WAS KNOTTED FIRST. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SUBSCAP REFIXATION SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 24-FEB-2021: IT WAS FURTHER REPORTED THAT WHEN THE THREADS ARE BLOCKED, NO SLIP KNOTS CAN BE MADE. THEREFORE A NORMAL KNOT WAS MADE FOR THE FIRST PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567522 ↗
• MalfunctionJun 18, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING BICEPS TENODESIS SURGERY BOTH ANCHORS DID NOT GRIPP. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT PART, SWIVE LOCK. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE, 16-MAR-2021 -SAC RECEIVED FURTHER INFORMATION THAT ANOTHER DRILL WAS NOT NECESSARY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 19558624 ↗
• MalfunctionJun 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SUTURE TAPE DOESN`T SLIDE PROPERLY IN THE DEVICE. IF THE INNER THREAD IS KNOTTED, THE OUTER THREAD WILL ALSO SLIDE, BUT IF THE OUTER THREAD IS KNOTTED FIRST, THE INNER THREAD NO LONGER SLIDES. DURING THE SUBSCAP REFIXATION SURGERY THE SUTURES WERE NOT TWISTED AND NOTHING ELSE WAS DONE WRONG, NEVERTHELESS THE OUTER THREAD COULD ONLY BE MOVED WITH A LOT OF FORCE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446040 ↗
• MalfunctionMay 20, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 12/05/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632 FIBERTAK SUTURE ANCHOR SHAFT BENT, AND AN AR-8990ST-2 FIBERTAK DX SUTURE ANCHOR INSERTER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19352141 ↗
• MalfunctionMay 8, 2024Positioning Failure; Positioning Failure

  ON 10/15/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE PHONE THAT AN AR-3632 FIBERTAK WOULD NOT SEAT. THIS WAS DISCOVERED DURING USE IN A SHOULDER ARTHROSCOPY ON (B)(6) 2021. THE ANCHOR WAS UNABLE TO BE SECURED AND WAS REMOVED. THE CASE WAS COMPLETED BY USING A DIFFERENT AR-3632.

  Patient problems: Insufficient Information

  MAUDE report 19267018 ↗
• MalfunctionMay 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632 FIBERTAK SUTURE ANCHOR PULLED OUT OF IMPLANTATION SITE. THIS WAS DISCOVERED DURING A PROCEDURE ON 1/9/2023. CASE WAS COMPLETED USING ANOTHER AR-3632 FIBERTAK SUTURE ANCHOR. ADDITIONAL INFORMATION RECEIVED ON 1/25/2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE, NOTHING BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258989 ↗
• MalfunctionMay 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PECTORAL TEAR SHOULDER SURGERY THE DEVICE TORE OUT. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE BY SWITCHING TO A CORK SCREW PROCEDURE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250667 ↗
• MalfunctionMay 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY TWO DEVICES TORE. NO PART OF THE DEVICES BROKE OFF. 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 19247008 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE TIP OF THE ANCHOR SNAPPED OFF. THE SURGEON WAS CONFIDENT THAT THE FRAGMENT IS IN THE PATIENTS BONE AND LEFT IT THERE. 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 19231555 ↗
• MalfunctionMar 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 02/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3632 FIBERTAK® SUTURE ANCHORS WHITE AND BLUE SUTURE TAPE WAS CUT IN HALF. THIS OCCURRED DURING A SHOULDER CASE ON (B)(6) 2024 BEFORE BEING PASSED WITH THE SCORPION. THE ANCHOR WAS EXPLANTED, AND A NEW AR-3633 WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18857841 ↗
• MalfunctionNov 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3632 FIBERTAK SUTURE ANCHOR, 2.6 MM, DOUBLE LOADED, WITH 1.3 MM SUTURETAPE (WHITE / BLUE, WHITE / BLACK) HAD AN ANCHOR MALFUNCTION. AFTER SOME PASSES, IT WAS NOTICED THAT THE SHEATH WAS HALFWAY OUT OF THE BONE, AND WHEN THE SURGEON PULLED ON THE SUTURE, THE ANCHOR PULLED OUT. IT WAS STATED THAT THE SUTURE WAS NOTICEABLY SHORT AFTER INSERTION. THE CASE WAS COMPLETED USING AR-3632-SP FIBERTAK SP SUTURE ANCHOR THAT STAYED IN THE BONE WITH NO ISSUES AND AR-7500 SUTURETAPE WHITE/BLUE 1.3 MM SUTURE WITH NEEDLE. THE CASE WAS DELAYED 2-3 MINUTES, AND NO FRAGMENTS WERE LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 18231993 ↗
• MalfunctionSep 15, 2023Break; Break

  ON (B)(6) 2023, AN FDA MAUDE NOTIFICATION WAS RECEIVED VIA EMAIL. AN UNKNOWN FACILITY REPRESENTATIVE REPORTED THAT AN AR-3632 FIBERTAK TIP BROKE. IT WAS NOTICED THAT ABOUT 1MM TO 2 MM OF THE INSERTER TIP HAD BROKEN OFF IN THE BONE. THE SURGEON INDICATED THAT THE TIP WAS UNRETRIEVABLE AND DETERMINED THAT IT WOULD BE SAFER FOR THE PATIENT TO LEAVE THE TIP PIECE IN PLACE INSTEAD OF TRYING TO RETRIEVE IT. THIS WAS DISCOVERED DURING A LEFT ARTHROSCOPIC PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 17754737 ↗
• MalfunctionApr 28, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632 DOUBLE LOADED FIBERTAK FORK-LIKE INSERTER TIP BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE NOT RETRIEVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE AND COMPLETED WITH THE SAME ANCHOR, AS IT COULD BE IMPLANTED SUCCESSFULLY, DESPITE THE BROKEN INSERTER TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 16838118 ↗
• MalfunctionApr 18, 2023Break; Detachment of Device or Device Component

  DURING LEFT SHOULDER ARTHROSCOPIC PROCEDURE, A 2.6MM ARTHREX FIBERTAK SUTURE ANCHOR (REF # AR-3632, LOT # 15036292, EXP. 11/30/2023), DOUBLE-LOADED WITH 1.3MM SUTURETAPE WAS USED. DURING THE PROCEDURE IT WAS NOTED THAT VERY TIP OF THE ANCHOR (APPROXIMATELY 1MM X 2MM IN SIZE) WAS MISSING AND HAD BROKEN OFF IN THE BONE. THE SURGEON INDICATED THAT THE TIP WAS APPROXIMATELY 1MM X 2MM IN SIZE) HAD BROKEN OFF IN THE BONE. THE SURGEON INDICATED THAT THE TIP WAS UNRETRIEVABLE AND DETERMINED THAT IT WOULD BE SAFER FOR THE PATIENT TO LEAVE THE TIP PIECE IN PLACE INSTEAD OF TRYING TO RETRIEVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16760851 ↗
• MalfunctionOct 24, 2022Break

  ON 10/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3632 FIBERTAK SUTURE ANCHOR BROKE. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON 10/3/2022. CASE WAS COMPLETED WITH ANOTHER AR-3632 FIBERTAK SUTURE ANCHOR WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 15657307 ↗