Arthrex® AR-3680Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00888867305441), received between Mar 2, 2021 and Jul 31, 2026 — classified as 90 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (51 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 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50105254 ↗
• MalfunctionMay 8, 2026Break; Device Dislodged or Dislocated

  ON 22-APR-2026, IT WAS REPORTED BY A SALES REP VIA PHONE THAT AN AR-3680 FIBERTAK BUTTON DIDN'T SET CORRECTLY. THE KNOTLESS MECHANISM DID NOT SET AND WOULD NOT PULL OUT. THE ANCHOR BODY WAS REPORTED TO HAVE BROKEN OFF. THE CASE WAS COMPLETED WITH AN AR-3681 FIBERTAK BUTTON. THIS OCCURRED DURING USE IN A BICEP TENODESIS CASE ON (B)(6) 2026, WITH NO PATIENT IMPACT. THERE WAS NO DELAY IN THE PROCEDURE OR ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123062 ↗
• MalfunctionFeb 19, 2026Device Dislodged or Dislocated

  ON 03-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. WHILE SHUTTLING THE REPAIR STITCH THROUGH THE ANCHOR, THE ENTIRE SHEATH WAS PULLED OUT. THE SHEATH WAS REMOVED, AND WHEN THE SURGEON ATTEMPTED TO TIE THE CONSTRUCT, THE ENTIRE ANCHOR SUBSEQUENTLY CAME OUT. THE CASE WAS COMPLETED USING A REPLACEMENT AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM. THIS OCCURRED DURING A BICEPS REPAIR PROCEDURE ON (B)(6) 2026. THERE WAS NO REPORTED PATIENT HARM. THE CASE WAS DELAYED APPROXIMATELY 15 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388298 ↗
• MalfunctionFeb 4, 2026Device Dislodged or Dislocated

  ON 14-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM PULLED OUT. THIS WAS DISCOVERED DURING A SUB PEC TENODESIS PROCEDURE WITH NO PATENT HARM. IT WAS REPORTED THAT THE SURGEON INSERTED THE ANCHOR AND SET THE ANCHOR ACCORDING TO THE TECHNIQUE, THEN WHEN HE WENT TO SHUTTLE THE FIRST SUTURE THROUGH THE ANCHOR, THE ANCHOR PULLED OUT. THE ANCHOR WAS RELOADED AND RE-INSERTED. THE SURGEON THEN WENT TO SHUTTLE THE FIRST SUTURE THROUGH THE ANCHOR AND THE ANCHOR PULLED OUT AGAIN. THE CASE WAS THEN COMPLETED WITH AN AR-2290.

  Patient problems: Insufficient Information

  MAUDE report 24257672 ↗
• MalfunctionJan 14, 2026Device Dislodged or Dislocated

  ON 30-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT THREE AR-3680 FIBERTAK BUTTON IMPLANT SYSTEMS PULLED OUT OF THE BONE WHILE SHUTTLING SUTURES. ATTEMPTS TO CONVERT DOWN TO THE ANCHOR WERE UNSUCCESSFUL, AS THE IMPLANTS CONTINUED TO PULL OUT INSTEAD OF CONVERTING. ALL THREE IMPLANTS WERE SUBSEQUENTLY REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM. THE ISSUE RESULTED IN AN APPROXIMATE 20-MINUTE SURGICAL DELAY, AND IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE EVENT OCCURRED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068771 ↗
• MalfunctionJan 14, 2026Device Dislodged or Dislocated

  ON 30-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT THREE AR-3680 FIBERTAK BUTTON IMPLANT SYSTEMS PULLED OUT OF THE BONE WHILE SHUTTLING SUTURES. ATTEMPTS TO CONVERT DOWN TO THE ANCHOR WERE UNSUCCESSFUL, AS THE IMPLANTS CONTINUED TO PULL OUT INSTEAD OF CONVERTING. ALL THREE IMPLANTS WERE SUBSEQUENTLY REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM. THE ISSUE RESULTED IN AN APPROXIMATE 20-MINUTE SURGICAL DELAY, AND IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE EVENT OCCURRED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068765 ↗
• MalfunctionJan 14, 2026Device Dislodged or Dislocated

  ON 30-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT THREE AR-3680 FIBERTAK BUTTON IMPLANT SYSTEMS PULLED OUT OF THE BONE WHILE SHUTTLING SUTURES. ATTEMPTS TO CONVERT DOWN TO THE ANCHOR WERE UNSUCCESSFUL, AS THE IMPLANTS CONTINUED TO PULL OUT INSTEAD OF CONVERTING. ALL THREE IMPLANTS WERE SUBSEQUENTLY REMOVED INTACT FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM. THE ISSUE RESULTED IN AN APPROXIMATE 20-MINUTE SURGICAL DELAY, AND IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE EVENT OCCURRED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068755 ↗
• MalfunctionNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3680 FIBERTAK® BUTTON IMPLANT SYSTEMS SECOND STITCH WOULD NOT PULL THROUGH THE ANCHOR. THIS OCCURRED DURING A ROTATOR CUFF BICEPS TENODESIS ON (B)(6) 2025, THE FIRST DEVICE PULLED OUT THE PATIENT AFTER THE STITCH WOULD NOT PULL THROUGH, THE SECOND DEVICE WAS ATTEMPTED AND THE SAME THING OCCURRED. A THIRD AR-3680 WAS USED AND WORKED ACCORDINGLY. THIS RESULTED IN A TEN-MINUTE DELAY AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 23633220 ↗
• MalfunctionNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/05/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3680 FIBERTAK® BUTTON IMPLANT SYSTEMS SECOND STITCH WOULD NOT PULL THROUGH THE ANCHOR. THIS OCCURRED DURING A ROTATOR CUFF BICEPS TENODESIS ON (B)(6) 2025, THE FIRST DEVICE PULLED OUT THE PATIENT AFTER THE STITCH WOULD NOT PULL THROUGH, THE SECOND DEVICE WAS ATTEMPTED AND THE SAME THING OCCURRED. A THIRD AR-3680 WAS USED AND WORKED ACCORDINGLY. THIS RESULTED IN A TEN-MINUTE DELAY AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 23633129 ↗
• MalfunctionNov 24, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3680 FIBERTAK® BUTTON IMPLANT SYSTEMS SECOND STITCH WOULD NOT PULL THROUGH THE ANCHOR. THIS OCCURRED DURING A ROTATOR CUFF BICEPS TENODESIS ON (B)(6) 2025, THE DEVICE REMAINED IN THE PATIENT AND THE SECOND STITCH WAS TIED TO THE FIRST STITCH OVER THE TENDON. THIS RESULTED IN A FIVE-MINUTE DELAY AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23632968 ↗
• MalfunctionOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/07/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM EXPERIENCED AN ISSUE DURING USE. THE BICEPS FIBERTAK ANCHOR PULLED OUT AS THE SURGEON ATTEMPTED TO PASS THE FIRST SUTURE THROUGH THE BUTTON. A REPLACEMENT AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE INCIDENT OCCURRED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2025, RESULTING IN A BRIEF SURGICAL DELAY OF APPROXIMATELY TWO MINUTES. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/09/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311350 ↗
• MalfunctionSep 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/22/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM WAS INSERTED INTO THE BONE DURING A PROCEDURE. AFTER THE TENDON WAS WHIPSTITCHED, THE SURGEON ATTEMPTED TO CONVERT THE SHUTTLING SUTURES, AT WHICH POINT THE ANCHOR PULLED OUT OF THE BONE. TO COMPLETE THE CASE, THE SURGEON IMPLANTED AN AR-2290, WHICH WAS INSERTED WITHOUT DIFFICULTY. THE PATIENT WAS NOT INJURED AS A RESULT OF THE FAILURE; HOWEVER, ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO PHOTOS OR VIDEOS WERE CAPTURED TO DOCUMENT THE DEVICE FAILURE. THIS ISSUE WAS IDENTIFIED DURING THE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08/28/2025: THE ISSUE WAS IDENTIFIED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. THE CASE WAS DELAYED FOR ONE MINUTE, WITH ONE MINUTE OF ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032190 ↗
• MalfunctionSep 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3680 FIBERTAK BUTTON FIRST SUTURE PASSED AND SECOND SUTURE PULLED OUT ENTIRE ANCHOR. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THERE WAS A 4 MINUTE DELAY. THE CASE WAS COMPLETED USING A NEW KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964352 ↗
• MalfunctionAug 29, 2025Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2025, A SALES REPRESENTATIVE VIA PHONE REPORTED THAT AN AR-3680 FIBERTAK® BUTTON IMPLANT SYSTEM HAD BENT. THIS OCCURRED DURING A SUBPECTORAL BICEPS TENODESIS ON (B)(6) 2025. THIS OCCURRED UPON INSERTION. THE DEVICE WAS REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-3680 IN ANOTHER LOCATION, REQUIRING A NEW HOLE TO BE DRILLED. THE PATIENT HAD GOOD BONE QUALITY. THIS RESULTED IN A 3-MINUTE DELAY WHERE NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 22925783 ↗
• MalfunctionAug 19, 2025Use of Device Problem; Use of Device Problem

  ON 08/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3680 FIBERTAK BUTTON LINK IN THE BUTTON DID NOT PULL THROUGH. THE SUTURES BUNCHED UP AND GOT STUCK IN THE BUTTONHOLE, AND IT BACKED ITSELF OUT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO DELAY TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839222 ↗
• MalfunctionAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/29/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3680 FIBERTAK BUTTON IMPLANT SYSTEMS HAD PULLED OUT OF THE BONE DURING THE CONVERSION OF SHUTTLING SUTURES FOLLOWING TENDON WHIPSTITCHING. BOTH ANCHORS WERE INSERTED ACCORDING TO THE TECHNIQUE GUIDE, USING THE DRILL PIN AND DRILL GUIDE PROVIDED IN THE KIT, BUT FAILED DURING THE SAME PROCEDURAL STEP AT DISTINCT ANATOMICAL LOCATIONS ALONG THE BICIPITAL GROOVE. TO COMPLETE THE CASE, AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM WAS SUCCESSFULLY IMPLANTED WITHOUT DIFFICULTY. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT DUE TO THE ISSUE. NO ADVERSE EFFECTS WERE REPORTED. THE FAILURE WAS IDENTIFIED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08/05/2025: THIS OCCURRED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. THE TWO FAILED AR-3680 FIBERTAK BUTTON IMPLANT SYSTEMS WERE REMOVED FROM THE PATIENT. THE SURGERY WAS DELAYED 15 MINUTES, AND APPROXIMATELY 15 MINUTES OF EXTRA ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803786 ↗
• MalfunctionAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/29/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3680 FIBERTAK BUTTON IMPLANT SYSTEMS HAD PULLED OUT OF THE BONE DURING THE CONVERSION OF SHUTTLING SUTURES FOLLOWING TENDON WHIPSTITCHING. BOTH ANCHORS WERE INSERTED ACCORDING TO THE TECHNIQUE GUIDE, USING THE DRILL PIN AND DRILL GUIDE PROVIDED IN THE KIT, BUT FAILED DURING THE SAME PROCEDURAL STEP AT DISTINCT ANATOMICAL LOCATIONS ALONG THE BICIPITAL GROOVE. TO COMPLETE THE CASE, AN AR-2290 PROXIMAL TENODESIS IMPLANT SYSTEM WAS SUCCESSFULLY IMPLANTED WITHOUT DIFFICULTY. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT DUE TO THE ISSUE. NO ADVERSE EFFECTS WERE REPORTED. THE FAILURE WAS IDENTIFIED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08/05/2025: THIS OCCURRED DURING A PROXIMAL BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. THE TWO FAILED AR-3680 FIBERTAK BUTTON IMPLANT SYSTEMS WERE REMOVED FROM THE PATIENT. THE SURGERY WAS DELAYED 15 MINUTES, AND APPROXIMATELY 15 MINUTES OF EXTRA ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803764 ↗
• MalfunctionJun 4, 2025Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  ON 05/14/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM HAD A LOOSE ANCHOR SHEATH ON THE INSERTER, MAKING IT ULTIMATELY TOO BIG TO IMPLANT. THEY TRIED TIGHTENING THE SUTURES BUT COULDN'T GET THE ANCHOR IMPLANTED. THE CASE WAS COMPLETED, AND NO ADDITIONAL DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 06/03/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140737 ↗
• MalfunctionApr 17, 2025Break; Break

  ON 4/4/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THE TIP OF AN INSERTER FROM AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM BROKE OFF IN THE PATIENT. THE BROKEN FRAGMENT WAS NOT RETRIEVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21859314 ↗
• MalfunctionFeb 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM HAD THE ANCHOR PULL OUT DURING A BICEP TENODESIS CASE. THEY OPENED A NEW KIT TO COMPLETE THE CASE. THERE WAS A FOUR MINUTE CASE DELAY DUE TO THE ISSUE THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/11/2025: THE ANCHOR AND SUTURE WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431865 ↗
• MalfunctionFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/24/2025, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM WAS PULLED OUT DURING USE. THEY OPENED A NEW KIT WITHOUT ISSUES TO COMPLETE THE CASE. DUE TO THE ISSUE, THERE WAS A FOUR-MINUTE CASE DELAY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A BICEP TENODESIS PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21345960 ↗
• MalfunctionJan 22, 2025Use of Device Problem; Physical Resistance/Sticking; Use of Device Problem; Physical Resistance/Sticking

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM FAILED WHEN TRYING TO CONVERT THE ANCHOR IN THE BICEP. THE FIBERTAK WAS SUCCESSFULLY IMPLANTED INTO THE BONE BUT WHEN TRYING TO CONVERT THE FIRST STITCH FROM THE FIBERLOOP, THE LINK FROM THE ANCHOR WOULDN'T CONVERT. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21210884 ↗
• MalfunctionDec 4, 2024Failure to Advance; Failure to Advance

  ON 11/5/024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAKS FROM TWO AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM WOULD NOT SEAT CORRECTLY UNDER THE CORTEX. A SECOND BONE HOLE WAS DRILLED WITH THE DRILL FROM THE KIT, BUT THE FIBERTAK ANCHORS STILL WOULD NOT SEAT. IT APPEARS LIKE THE ANCHORS WOULD NOT TIGHTEN TO BALL UP UNDER THE CORTEX. SEVERAL ATTEMPTS WERE MADE WITH ALL BEING UNSUCCESSFUL. THIS WAS DISCOVERED DURING A SHOULDER SCOPE WITH THE BICEPS TENODESIS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 11/14/2024: BOTH AR-3680 FIBERTAK BUTTON WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2290 BICEPS TENODESIS. THE CASE WAS DELAYED FOR ABOUT FIFTEEN MINUTES; HOWEVER, THE SALES REPRESENTATIVE WAS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844150 ↗
• MalfunctionDec 4, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FIBERTAKS FROM TWO AR-3680 FIBERTAK BUTTON IMPLANT SYSTEM WOULD NOT SEAT CORRECTLY UNDER THE CORTEX. A SECOND BONE HOLE WAS DRILLED WITH THE DRILL FROM THE KIT, BUT THE FIBERTAK ANCHORS STILL WOULD NOT SEAT. IT APPEARS LIKE THE ANCHORS WOULD NOT TIGHTEN TO BALL UP UNDER THE CORTEX. SEVERAL ATTEMPTS WERE MADE WITH ALL BEING UNSUCCESSFUL. THIS WAS DISCOVERED DURING A SHOULDER SCOPE WITH THE BICEPS TENODESIS PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 11/14/2024: BOTH AR-3680 FIBERTAK BUTTON WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2290 BICEPS TENODESIS. THE CASE WAS DELAYED FOR ABOUT FIFTEEN MINUTES; HOWEVER, THE SALES REPRESENTATIVE WAS UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843798 ↗
• MalfunctionOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED ON 10/2/2024: THIS WAS DISCOVERED DURING A SUBPECTORAL TENODESIS PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED TEN TO FIFTEEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20385970 ↗