Arthrex® AR-3687Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867398757), received between Mar 4, 2024 and Mar 26, 2026 — classified as 16 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SUBPECTORAL BICEPS TENODESIS, THE TIPS OF THE INSERTER BROKE OFF. THESE REMAINED IN THE PATIENT. PRIOR TO THIS, THE INSERTER HAD BENT SEVERAL TIMES AT THE TIP. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24698658 ↗
• MalfunctionMar 23, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SUBPECTORAL BICEPS TENODESIS, THE TIPS OF THE INSERTER BROKE OFF. THESE REMAINED IN THE PATIENT. PRIOR TO THIS, THE INSERTER HAD BENT SEVERAL TIMES AT THE TIP. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24665178 ↗
• MalfunctionMar 23, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SUBPECTORAL BICEPS TENODESIS, THE TIPS OF THE INSERTER BROKE OFF. THESE REMAINED IN THE PATIENT. PRIOR TO THIS, THE INSERTER HAD BENT SEVERAL TIMES AT THE TIP. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24665065 ↗
• MalfunctionMar 23, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SUBPECTORAL BICEPS TENODESIS, THE TIPS OF THE INSERTER BROKE OFF. THESE REMAINED IN THE PATIENT. PRIOR TO THIS, THE INSERTER HAD BENT SEVERAL TIMES AT THE TIP. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24664932 ↗
• MalfunctionMar 23, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SUBPECTORAL BICEPS TENODESIS, THE TIPS OF THE INSERTER BROKE OFF. THESE REMAINED IN THE PATIENT. PRIOR TO THIS, THE INSERTER HAD BENT SEVERAL TIMES AT THE TIP. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24664686 ↗
• MalfunctionMar 23, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SUBPECTORAL BICEPS TENODESIS, THE TIPS OF THE INSERTER BROKE OFF. THESE REMAINED IN THE PATIENT. PRIOR TO THIS, THE INSERTER HAD BENT SEVERAL TIMES AT THE TIP. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24664361 ↗
• MalfunctionSep 9, 2025Break; Break

  ON 08/19/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING A ROTATOR CUFF REPAIR WITH A BICEPS TENODESIS PROCEDURE PERFORMED ON (B)(6) 2025, THREE AR-3687 KNOTLESS FIBERTAK BICEPS DEVICES EXPERIENCED BREAKAGE OF THE METAL INSERTER TINES, WHICH REMAINED INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE IMPLANTS WERE IMPLANTED AND LEFT IN PLACE. NO OTHER PRODUCTS WERE USED TO COMPLETE THE CASE. A 15-MINUTE DELAY WAS REPORTED, THOUGH IT REMAINS UNCERTAIN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM DRILLS PREPARED THE BONE SOCKET FOR IMPLANT INSERTION. BONE QUALITY WAS ASSESSED AS AVERAGE. NO ADDITIONAL SURGERY HAS BEEN PLANNED, AND NO ADVERSE EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23003919 ↗
• MalfunctionSep 9, 2025Break; Break

  ON 08/19/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING A ROTATOR CUFF REPAIR WITH A BICEPS TENODESIS PROCEDURE PERFORMED ON (B)(6) 2025, THREE AR-3687 KNOTLESS FIBERTAK BICEPS DEVICES EXPERIENCED BREAKAGE OF THE METAL INSERTER TINES, WHICH REMAINED INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE IMPLANTS WERE IMPLANTED AND LEFT IN PLACE. NO OTHER PRODUCTS WERE USED TO COMPLETE THE CASE. A 15-MINUTE DELAY WAS REPORTED, THOUGH IT REMAINS UNCERTAIN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM DRILLS PREPARED THE BONE SOCKET FOR IMPLANT INSERTION. BONE QUALITY WAS ASSESSED AS AVERAGE. NO ADDITIONAL SURGERY HAS BEEN PLANNED, AND NO ADVERSE EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23003918 ↗
• MalfunctionSep 9, 2025Break; Break

  ON 08/19/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT DURING A ROTATOR CUFF REPAIR WITH A BICEPS TENODESIS PROCEDURE PERFORMED ON (B)(6) 2025, THREE AR-3687 KNOTLESS FIBERTAK BICEPS DEVICES EXPERIENCED BREAKAGE OF THE METAL INSERTER TINES, WHICH REMAINED INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE IMPLANTS WERE IMPLANTED AND LEFT IN PLACE. NO OTHER PRODUCTS WERE USED TO COMPLETE THE CASE. A 15-MINUTE DELAY WAS REPORTED, THOUGH IT REMAINS UNCERTAIN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM DRILLS PREPARED THE BONE SOCKET FOR IMPLANT INSERTION. BONE QUALITY WAS ASSESSED AS AVERAGE. NO ADDITIONAL SURGERY HAS BEEN PLANNED, AND NO ADVERSE EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23003917 ↗
• MalfunctionAug 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE DEVICE BROKE. 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 22687746 ↗
• MalfunctionDec 5, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3687 BICEPS KNOTLESS FIBERTAK WHITE SUTURE WOULD NOT MOVE WHEN ATTEMPTING THE REDUCE IT. EVENTUALLY, THE SUTURE BROKE UNDER PRESSURE. THE SURGEON ARCHIVED FINAL FIXATION AND COMPLETED THE PROCEDURE BY ALTERNATIVE MEANS. THIS WAS DISCOVERED DURING A PROCEDURE ON 11/6/2024. ADDITIONAL INFORMATION RECEIVED ON 11/21/2024: THIS WAS DISCOVERED DURING A SUBPECTORAL BICEPS TENODESIS. THE ANCHOR REMAINED IN THE PATIENT AS A PORTION OF THE SUTURE WAS STILL USABLE. WITH THE USE OF A FREE NEEDLE, THE SUTURE WAS USED TO REPAIR THE TISSUE IN AN OFF-TECHNIQUE MANNER DUE TO THE DEVICE COMPLICATIONS. THE CASE WAS DELAYED TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20854589 ↗
• MalfunctionSep 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER / BICEPS TENDON SURGERY THE DEVICE BECAME BENT AT THE BEGINNING OF THE SURGERY. 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 DW 20-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN FRAGMENT WHICH WAS FOUND DURING THE INVESTIGATION DID NOT BREAK OFF DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333481 ↗
• MalfunctionSep 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3687 KNOTLESS TENSIONABLE FIBERTAK BICEPS WAS REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2024 IN ASCOT HOSPITAL DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE ANCHOR WAS IMPLANTED AND WHEN TRYING TO SHUTTLE THE KNOTLESS MECHANISM, THE ANCHOR FAILED AND JAMMED PREMATURELY. IT WAS STUCK AND WAS UNABLE TO DEPLOY. THE SURGEON HAD TO REMOVE ANCHOR AND IMPLANT AN ANOTHER. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER ANCHOR. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20257704 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3687 KNOTLESS FIBERTAK INSERTER BENT DURING INSERTION. DUE TO AN UNAVAILABLE AR-3688 KNOTLESS FIBERTAK BICEPS IMPLANT SYSTEM, THE SURGEON USED AN AR-1941DS DISPOSABLE INSTRUMENT KIT, AN AR-2923DT-ST DRILL AND THE AR-3687 KNOTLESS FIBERTAK. THE FIBERTAK ENCOUNTERED FRICTION WHILE GOING DOWN THE DRILL, RESULTING IN THE FIBERTAK INSERTER BENDING. ANOTHER ANCHOR WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19606969 ↗
• MalfunctionApr 29, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-3687 KNOTLESS FIBERTAKS TIP BROKE OFF. THIS OCCURRED DURING AN OPEN SUBPECTORAL BICEPS TENODESIS ON (B)(6) 2024 WHEN THE FORKED TIP BROKE OFF. THE BROKEN FRAGMENT COULD NOT BE RETRIEVED. ADDITIONAL INFORMATION RECEIVED ON 4/9/2024: THE CASE WAS COMPLETED WITH THE BROKEN IMPLANT STILL IN THE PATIENT AND THE ANCHOR USED AS DESIGNED. ADDITIONAL X-RAYS WERE NECESSARY TO LOCATE AND CONFIRM THE BROKEN PIECE OF THE INSERTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 19201033 ↗
• MalfunctionMar 4, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 02/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3687 KNOTLESS BICEPS FIBERTAK SHAFT BENT UPON INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-3687 KNOTLESS BICEPS FIBERTAK IN THE SAME DRILLED BONE HOLE. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 2/21/24: THE PROCEDURE PERFORMED WAS A SUBPEC BICEPS TENODESIS. THE DEVICE BENT AND DID NOT BREAK IN ANY WAY WHILE IN USE.

  Patient problems: Insufficient Information

  MAUDE report 18826721 ↗