Arthrex® AR-3671DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867305410), received between Jun 23, 2020 and Mar 6, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  ON 13-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3671 FIBERTAK® BICEPS IMPLANT BROKE, AND ADDITIONALLY REPORTED VIA (B)(4) THAT IT WAS BEING USED WITH AN AR-3671DS FIBERTAK® BICEPS DISPOSABLES KIT THAT FELL APART. THIS OCCURRED DURING AN OPEN BICEPS PROCEDURE ON (B)(6) 2026. WHILE DRILLING, THE PLASTIC CAME APART FROM THE METAL ON THE AR-3671DS FIBERTAK® BICEPS DISPOSABLES KIT, CAUSING THE AR-3671 IMPLANT TO BREAK. ALL FRAGMENTS WERE RECOVERED FROM THE PATIENT. THERE WAS A 30-SECOND DELAY. THE CASE PROCEEDED USING ANOTHER AR-3671 AND AR-3671DS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530772 ↗
• MalfunctionJan 13, 2026Positioning Failure; Physical Resistance/Sticking

  ON 31-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3671DS FIBERTAK BICEPS INSTRUMENT SET, DRILL WOULD NOT GO THROUGH THE GUIDE. IT GOT STUCK IN THE GUIDE WHEN THE SURGEON WAS ATTEMPTING TO DRILL. THE ANCHOR DID NOT DEPLOY, SO THEY HAD TO DRILL IN A DIFFERENT LOCATION. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 24053868 ↗
• MalfunctionAug 12, 2025Material Fragmentation; Material Fragmentation

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3671DS, FIBERTAK® BICEPS DISPOSABLES KIT, WHILE PREPARING DRILL TUNNEL FOR THE ANCHORS, THE FIBERTAK BICEPS DRILL (AR-3671DS) CAME LOOSE FROM THE BLUE PLASTIC OF THE DRILL GUIDE. IT APPEARED THAT THE DRILL WAS SPINNING FREELY INSIDE THE DRILL GUIDE AND 'MELTED' OFF FROM THE PLASTIC. PLEASE FIND PHOTOS ATTACHED. THE DRILL WAS THEN STUCK INSIDE THE METAL PART OF THE DRILL GUIDE AND THEREFORE THEY WERE UNABLE TO USE THE (ALREADY OPENED) ANCHORS TO INSERT THROUGH THE GUIDE. THEY DID NOT HAVE A SPARE DRILL GUIDE (AR-3671DS) AND THEREFORE THE 2X OPEN ANCHORS, AR-3671, FIBERTAK® BICEPS IMPLANT WERE UNABLE TO BE USED. THIS WAS DETECTED DURING USE IN A R SUB PECT BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SURGEON WAS ABLE TO USE A PECT BUTTON TO SECURE THE TENODESIS INSTEAD (AR-2267 WITH 3.7 DRILL PIN AR-2272). ALL INCIDENCES OCCURRED OUTSIDE THE JOINT. ALL FRAGMENTS REMOVED AND DISCARDED BY THE FACILITY. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THE PLASTIC PART BROKE OFF AND SPUN INSIDE THE DRILL WHILE ATTEMPTING TO USE THE DRILL, IN SURGICAL FIELD. O

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

  MAUDE report 22781803 ↗
• MalfunctionJun 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DRILL FUSED INSIDE THE GUIDE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498575 ↗
• MalfunctionDec 20, 2023Melted; Melted

  IT WAS REPORTED THAT DURING A BICEPS TENODESIS SURGERY THE METAL SLEEVE ROTATED IN THE BLUE PLASTIC, CAUSING HEAT DEVELOPMENT AND THE PLASTIC MELTED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE, AR-1923BC-1 AND THE THREADS OF THE FIBERTAK WERE INSERTED WITH A PUSHLOCK. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367478 ↗
• MalfunctionOct 30, 2023Melted; Melted

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE, VIA EMAIL, THAT WHILE DRILLING WITH THE 1.9 MM DRILL WITH THE INSERTER FROM AN AR-3671DS FIBERTAK BICEPS DISPOSABLES KIT, THE DRILL BECAME VERY HOT AND MELTED THE INSIDE OF THE INSERTER AND COULDN'T BE REMOVED FURTHER. ANOTHER FIBERTAK BICEPS DISPOSABLES KIT WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A DISTAL BICEP REPAIR ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 12/17/2022: NOTHING BROKE NOR MELTED INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18030690 ↗
• MalfunctionJul 3, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON THE (B)(6) 2023 IT WAS ADVISED VIA EMAIL FOR A AR-3671, (FIBERTAK® BICEPS IMPLANT) - BATCH# 15001308 AND AN AR-3671DS, (FIBERTAK® BICEPS DISPOSABLES KIT) - BATCH# 14974144. WHEN COMPLETING BICEP TENODESIS WITH FIBERTAK BICEP IMPLANT. WHEN USING THE DISPOSABLE DRILL KIT, DRILL SEIZED (COLD WELDED I THINK) AGAINST INSERTED AND COULD NOT BE PUSHED BEYOND THIS POINT. UNABLE TO COMPLETE THE DRILLING FOR ANCHOR AND THEREFORE UNABLE TO USE THE ANCHOR. HAD TO BAIL TO AN ALTERNATIVE PRODUCT TO COMPLETE THE TENODESIS. THE PROCEDURE WAS COMPLETED USING 2.6 FIBERTAK WITH REUSABLE DRILL. THERE WAS A CASE AND PATIENT INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 17247468 ↗
• MalfunctionMar 2, 2021Break; Entrapment of Device; Failure to Advance

  IT WAS REPORTED DURING A BICEPS TENODESIS PROCEDURE THE SURGEON WAS USING AR-3671DS. AS THE SURGEON BEGAN TO DRILL, THE DRILL GOT CAUGHT IN THE DRILL SLEEVE. THEY WERE NO LONGER ABLE TO ADVANCE THE DRILL AND AT SOME POINT THE DRILL BROKE IN HALF. ANOTHER AR-3671DS WAS OPENED AND WORKED WITHOUT ISSUE. THE REP REPORTED THERE WAS NO HARM TO THE PATIENT AND ALL BROKEN FRAGMENTS WERE FULLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398264 ↗
• InjuryJun 23, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE DISPOSABLE DRILL WITHIN THE AR-3671DS, FIBERTAK BICEPS INSTRUMENT SET COLD FUSED WITH THE DISPOSABLE GUIDE. THE GUIDE WAS PLACED INTO SUB PEC IN THE PROX HUMERUS, AND WHEN THE DRILL WAS INSERTED INTO GUIDE THE DRILL FUSED WITH THE GUIDE. THE DRILL AND GUIDE WERE INTACT WHEN REMOVED. THE SALES REP REPORTED THERE WAS NO HARM TO THAT PATIENT. ADDITIONAL INFORMATION OBTAINED 6/4/2020: THE PROCEDURE WAS A BICEP TENODESIS. WHEN THE DRILL FUSED WITH THE GUIDE THE SALES REP OPENED ANOTHER DRILL WITH GUIDE. THE SURGEON DRILLED AGAIN AND IT MADE THE TUNNEL TOO BIG AND THE ANCHOR PULLED OUT. THE DOCTOR DECIDED NOT TO REPAIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184980 ↗