Arthrex® AR-3688Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867398740), received between Dec 14, 2023 and Sep 15, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Defective Device

  It was reported that during the bicep's surgery, it was almost impossible to insert the anchor through the drill sleeve after drilling. A hammer was needed to put it though the sleeve and into the bone. The first FiberTak bent completely. The second FiberTak was put into the bone, but the sutures were damaged so that sliding mechanism did not work anymore. At the end they had to tie knots with the remaining sutures. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777879 ↗
• MalfunctionSep 15, 2026Material Twisted/Bent

  It was reported that during the bicep's surgery, it was almost impossible to insert the anchor through the drill sleeve after drilling. A hammer was needed to put it though the sleeve and into the bone. The first FiberTak bent completely. The second FiberTak was put into the bone, but the sutures were damaged so that sliding mechanism did not work anymore. At the end they had to tie knots with the remaining sutures. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777297 ↗
• MalfunctionFeb 23, 2026Device Dislodged or Dislocated

  ON 9TH FEBRUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3688, KNOTLESS TENSIONABLE FIBERTAK BICEPS KIT, THE ANCHOR PULLED OUT DURING FINAL TENSIONING OF KNOTLESS MECHANISM. THE SURGEON FOLLOWED THE INSTRUCTIONS GIVEN AND TECH GUIDE. IT WAS CONFIRMED WHETHER IT WAS INSERTED INTO SOFT BONE AND THE SURGEON REASSURED THAT IT WASN'T SOFT BONE (61-YEAR-OLD MALE PT). THIS WAS DETECTED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON OPENED SUBSEQUENT ANCHOR (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A DIFFERENT IMPLANT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 24416101 ↗
• MalfunctionNov 5, 2025Failure to Advance; Failure to Advance

  ON 10/28/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM WAS VERY DIFFICULT TO ADVANCE THROUGH THE GUIDE AND WOULD NOT EXIT THE DISTAL TIP. NO BREAKAGE WAS REPORTED DURING THE ISSUE, AND THE DEVICE WAS REMOVED WITHOUT INCIDENT. THE SURGEON EXPRESSED CONCERN ABOUT THE AMOUNT OF FORCE REQUIRED TO MALLET AND INSERT THE KNOTLESS FIBERTAK BICEPS ANCHOR THROUGH THE GUIDE. THE CASE WAS COMPLETED USING TWO AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHORS WITH #5 SUTURE. THE ISSUE CAUSED A FIVE-MINUTE DELAY IN THE PROCEDURE, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE BONE WAS PREPARED FOR IMPLANT INSERTION USING THE DRILL PROVIDED IN THE KIT, AND THE BONE QUALITY WAS ASSESSED AS EXCELLENT. THIS ISSUE WAS DISCOVERED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477689 ↗
• MalfunctionJul 23, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM HAD AN ISSUE DURING THE ANCHOR'S TENSIONING PHASE. THE TENSIONING LOOP WOULD NOT CONVERT TO FULLY TENSION THE BICEPS DOWN TO THE ANCHOR. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/10/2025: THE CASE WAS COMPLETED USING ALTERNATIVE FIXATION WITH AR-7535 FIBERLINK 1.3MM SUTURE TAPE AND AR-1926BCSP BIOCOMPOSITE PUSHLOCK ANCHOR. THE PROCEDURE WAS DELAYED FOR LESS THAN ONE MINUTE, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO ADVERSE EFFECTS WERE OBSERVED DURING OR FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584032 ↗
• MalfunctionJul 21, 2025Break; Break

  ON 06/26/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3688 KNOTLESS TENSIONABLE FIBERTAK BICEPS KIT HAD A PIECE OF THE DEVICE BREAK OFF INTO THE HUMUS OF THE PATIENT. THE BROKEN PIECE COULD NOT BE RETRIEVED AND IS STILL INSIDE THE PATIENT. THIS WAS DISCOVERED DURING THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22554995 ↗
• MalfunctionApr 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 3/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM BLUE SHUTTLE STITCH WAS ALREADY CUT AND MADE THE ANCHOR UNUSABLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21760878 ↗
• MalfunctionJan 3, 2025Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE PRONGS OF THE INSERTER FROM AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM BROKE OFF DURING INSERTION. THIS WAS DISCOVERED DURING A SUBPECTORAL BICEP TENODESIS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 12/16/2024: THE LOT NUMBER REMAINS UNKNOWN. THE IMPLANT REMAINED IN THE PATIENT, AND THE BROKEN FRAGMENTS COULD NOT BE RETRIEVED. THE CASE WAS COMPLETED USING AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21066871 ↗
• MalfunctionDec 26, 2024Break; Positioning Failure; Break; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM SUTURES WOULD NOT TENSION DOWN THE BLUE REPAIR STITCH. THE SURGEON DESCRIBED THE ISSUE AS HAVING SOME SLACK OR BEING LOOSE. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21020012 ↗
• MalfunctionDec 26, 2024Break; Positioning Failure; Break; Positioning Failure

  ON 12/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM SUTURES WOULD NOT TENSION DOWN THE BLUE REPAIR STITCH. THE SURGEON DESCRIBED THE ISSUE AS HAVING SOME SLACK OR BEING LOOSE. THIS WAS DISCOVERED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 21019257 ↗
• MalfunctionOct 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM HAD ISSUES. WHILE DRILLING, THE DRILL HAD SOME RESISTANCE AND SEEMED TIGHTER THAN THE NORMAL SLIDE. WHEN INSERTING THE ANCHOR INTO THE SHEATH, IT WOULD GO IN ABOUT HALF AN INCH AND THEN IT WAS SO TIGHT THAT THE ANCHOR WOULD NOT SLIDE THROUGH. THE SURGEON ATTEMPTED TO MALLET IN THE ANCHOR BUT WAS UNSUCCESSFUL. THE CASE WAS COMPLETED USING ANOTHER AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. ADDITIONAL INFORMATION RECEIVED ON 10/17/2024: THIS WAS DISCOVERED DURING AN OPEN PROXIMAL BICEPS TENODESIS. THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 20528724 ↗
• MalfunctionOct 1, 2024Break; Break

  ON 9/19/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE TIP OF THE FIBERTAK FROM AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM BROKE OFF IN THE PATIENT'S HUMERUS. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) 2024.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20345095 ↗
• MalfunctionSep 13, 2024Defective Device; Defective Device

  ON 8/30/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ANAR-3688 KNOTLESS FIBERTAK WHITE CONVERTING LOOP WAS TOO SHORT. THE SURGEON WAS ABLE TO MAKE IT LONGER BY PULLING ON IT, BUT IT WAS DIFFICULT. THE CASE WAS COMPLETED SUCCESSFULLY WITH A DELAYED OF LESS THAN FIFTEEN MINUTES. THE KNOTLESS FIBERTAK ANCHOR WAS LEFT IMPLANTED. THIS WAS DISCOVERED DURING AN OPEN PROXIMAL BICEP REPAIR ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20217793 ↗
• MalfunctionJun 28, 2024Use of Device Problem; Use of Device Problem

  ON 5/31/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3688 KNOTLESS FIBERTAK COULD NOT BE CINCHED DOWN. UPON TRYING TO REDUCE THE KNOTLESS WHITE LOOP AT THE END OF THE PROCEDURE, THE SURGEON ENCOUNTERED SOME RESISTANCE, AND ULTIMATELY, COULD NOT REDUCE THIS STITCH. THE SURGEON CUT OUT THE KNOTLESS FIBERTAK AND PROCEEDED TO USE A NEW IMPLANT. THIS WAS DISCOVERED DURING AN OPEN ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 6/7/2024. THE CASE WAS COMPLETED USING ANOTHER AR-3688 KNOTLESS FIBERTAK. THE SUTURES WERE CUT; HOWEVER, SOME OF THE ANCHOR REMAINS IN THE PATIENT. NOTHING BROKE OFF IN THE PATIENT. THE CASE WAS SLIGHTLY DELAYED WITH MINIMAL ANESTHESIA ADMINISTRATION TO THE PATIENT. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632105 ↗
• MalfunctionJun 14, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BLUE REPAIR STITCH FROM AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM LOCKED UP AND WOULD NOT CINCH. THE ANCHOR WAS CUT OUT AND A NEW ONE WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 19537555 ↗
• MalfunctionMay 23, 2024Defective Device; Defective Device

  ON 4/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM DID NOT CINCH ALL THE WAY DOWN, LEAVING LOOPS OF SUTURE INSIDE THE PATIENT. THE SUTURE HAD IT BE CUT OUT AS IT DID NOT PROVIDE ANY FIXATION OF THE BICEPS. THE ANCHOR BODY REMAINS IN THE PATIENT. THIS WAS DISCOVERED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 19383332 ↗
• MalfunctionMay 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 4/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3636 KNOTLESS 1.8 FIBERTAK WOULD NOT PASS THROUGH AND GOT STUCK. THE SURGEON HAD TO CUT IT OUT AS THE IMPLANT WOULD NOT REDUCE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19271375 ↗
• MalfunctionJan 17, 2024Material Fragmentation; Material Fragmentation

  ON 12/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAK ANCHOR FROM AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM WOULD NOT GO DOWN THE DRILL GUIDE AND BROKE THE ANCHOR INSERTER. THIS WAS DISCOVERED DURING A SUBPEC TENODESIS PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED INDICATED THE DRILL GUIDE WAS INSIDE THE PATIENT, AND THE FIBERTAK INSERTER WAS INSIDE THE DRILL GUIDE WHEN IT BROKE; HOWEVER, THE FRAGMENTS OF THE FIBERTAK WERE CONTAINED INSIDE THE DRILL GUIDE, AND NOTHING WAS LOOSE INSIDE THE PATIENT. THE CASE WAS COMPLETED BY USING AN AR-1665BCSL 4.75 BC LOOP 'N' TACK¿ TENODESIS IMPLANT SYSTEM. THE CASE WAS DELAYED TEN MINUTES WITHOUT NEEDING ADDITIONAL ANESTHESIA. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528247 ↗
• MalfunctionJan 12, 2024Failure to Advance; Failure to Advance

  ON 12/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT THE FIBERTAK FROM AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM WOULD NOT DELIVER DOWN THE GUIDE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS WAS DISCOVERED DURING A SHOULDER SCOPE BICEP TENODESIS PROCEDURE. THE FIBERTAK IMPLANT GOT STUCK AND WOULD NOT GO DOWN THE GUIDE; NOTHING BROKE INSIDE THE PATIENT. ANOTHER AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM WAS USED TO COMPLETE THE CASE FROM A DIFFERENT LOT NUMBER. THE CASE WAS DELAYED TEN MINUTES, BUT THE SALES REPRESENTATIVE IS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507958 ↗
• MalfunctionJan 9, 2024Contamination; Contamination

  ON 12/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-3688 KNOTLESS FIBERTAK HAD A CONTAMINANT IN THE PACKAGING. THIS OCCURRED DURING A BICEP TENODESIS ON (B)(6) 2023, WHERE THE PROCEDURE WAS COMPLETED. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477960 ↗
• InjuryJan 3, 2024Fitting Problem; Failure to Advance; Fitting Problem; Failure to Advance

  ON 12/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3688 FIBERTAK IMPLANT SYSTEM ANCHOR WOULD NOT FIT THROUGH THE GUIDE. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY IN CASE. CASE COMPLETED USING DIFFERENT IMPLANT, CONSTRUCT STAYED THE SAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437488 ↗
• MalfunctionDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE GUIDE FROM AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM WAS TOO TIGHT AND THE IMPLANT COULD NOT FIT THROUGH IT. THE SURGEON HAD TO USE FORCE TO INSERT THE IMPLANT INTO THE GUIDE WHICH CAUSED BONE DAMAGE, CREATED A LARGER SIZE BONE HOLE, AND THE ANCHOR PULLED OUT. THE CASE WAS COMPLETED BY USING A FORK-TIP SWIVELOCK. THIS WAS DISCOVERED DURING A ARTHROSCOPIC BICEPS TENODESIS PROCEDURE ON (B)(6) 2023.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 18367468 ↗
• MalfunctionDec 14, 2023Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL SLEEVE FROM AN AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM WAS NOT LARGE ENOUGH FOR THE FIBERTAK ANCHOR. AFTER DRILLING, THE SURGEON COULD NOT GET THE ANCHOR INTO THE SLEEVE. THE SURGEON HAD TO START OVER AND USE A 2.6 KNOTLESS FIBERTAK DRILL SLEEVE TO DRILL A SECOND BONE HOLE AND IMPLANT THE FIBERTAK ANCHOR. AFTER FOLLOWING THE PROPER TECHNIQUE TO SUTURE THE BICEP, THE KNOTLESS MECHANISM IN THE ANCHOR WOULD NOT CLOSE DOWN. THE SURGEON ATTEMPTED TO DO THIS FOR ABOUT TEN MINUTES BEFORE CUTTING THE SUTURES AND FIXATING WITH A SWIVELOCK IN A THIRD BONE HOLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 11/20/2023: THE CASE WAS COMPLETED USING AN AR-2324KBCCT BIOCOMPOSITE KNOTLESS SWIVELOCK. THE SECOND PILOT HOLE WAS CREATED WITH AN AR-1941DS KNOTLESS CORKSREWS DISPOSABLE INSTRUMENT KIT. THE THIRD BONE SOCKET WAS CREATED USING A 4.75 PUNCH. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE. THE CASE WAS DELAYED ABOUT TEN MINUTES. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325520 ↗