Arthrex® AR-3671Recalls & reported problems
Arthrex, Inc. · FiberTak Biceps Implant · Class 2 · Implant
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888867305403), received between Mar 29, 2021 and Mar 6, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated7
- Break3
- Device Damaged Prior to Use2
- Failure to Advance2
- Detachment of Device or Device Component1
- Material Twisted/Bent1
- Physical Resistance/Sticking1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information7
- Failure of Implant1
- Foreign Body In Patient1
Recent adverse event reports
The 19 most recent of 19 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 24530703 ↗MalfunctionDec 29, 2025Use of Device Problem; Use of Device Problem
ON (B)(6) 2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3671 FIBERTAK BICEPS IMPLANT HAD ONE NEEDLE SKEWERED THROUGH THE SUTURE TAPE OF ANOTHER SUTURE, CAUSING TANGLING STRAIGHT OUT OF THE BOX. THIS WAS NOTICED AFTER INSERTION WHEN THE IMPLANT WAS UNWOVEN FROM THE INSERTER. THE NEEDLE WAS UNSKEWERED, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUE. THIS WAS DISCOVERED DURING A BICEPS TENODESIS / CUFF PROCEDURE ON (B)(6) 2025.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 23906711 ↗MalfunctionOct 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 15TH OCTOBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3671, FIBERTAK® BICEPS IMPLANT, THE IMPLANT WAS FAULTY AND CAME OUT OF THE BONE. THIS WAS DETECTED DURING USE IN A BICEPS TENODESIS PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER FIBERTAK BICEPS IMPLANT WAS OPENED WHICH WORKED.
Patient problems: Insufficient Information
MAUDE report 23312678 ↗MalfunctionJun 5, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING AN OPEN PROXIMAL BICEPS REPAIR SURGERY BOTH ANCHORS REFUSED TO DEPLOY. SECOND DRILL HILD MADE, BUT SAME ISSUE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE AR-3632SP-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22148555 ↗MalfunctionJan 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 08/03/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3671 SUTURE ANCHOR BACKED OUT OF THE BONE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112357 ↗MalfunctionJun 13, 2024Failure to Advance; Failure to Advance
ON (B)(6) 2023, IT WAS REPORTED VIA EMAIL THAT AN AR-3671 (FIBERTAK BICEPS IMPLANT) FAILED TO DEPLOY AND WAS UNABLE TO BE SET. THIS OCCURRED DURING BICEPS TENODESIS PROCEDURE ON (B)(6) 2023. PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER SURGEON DRILLED A SECOND HOLE AND DEPLOYED ANOTHER ANCHOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19529349 ↗MalfunctionJun 11, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
ON 4/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3671 FIBERTAK BICEPS IMPLANT SYSTEM AND AN AR-6370 FIBERTAK IMPLANT SYSTEM SUTURES WERE FRAYED CLOSE TO THE SHEATH. THE SURGEON WAS ABLE TO SLIDE THE SUTURE THROUGH THE IMPLANT AND STILL USE THE REMAINING LENGTH. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 4/20/2023: THIS WAS DISCOVERED DURING AN MPFL REPAIR WITH ALLOGRAFT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19512165 ↗MalfunctionMay 13, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
ON 10/05/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3671 BICEPS IMPLANT SHEATH ON THE FIBERTAK WAS DAMAGED AND WOULD NOT FACILITATE IMPLANT TO SET. THE IMPLANT WAS WASTED AND THE CASE WAS COMPLETED USING A 3.0 SUTURETAK. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19298181 ↗MalfunctionMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A MPFL PROCEDURE, AFTER THE SURGEON IMPLANTED THE ANCHORS AND REMOVED THE AR-3671 FROM THE PATIENT, THE ANCHOR CAME RIGHT OUT OF THE BONE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19298136 ↗MalfunctionMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING A PROXIMAL HAMSTRING REPAIR THE ANCHOR WAS IMPLANTED BUT PULLED BACK OUT WHILE SECURING THE SUTURE. THE SURGEON DRILLED ANOTHER HOLE AND RELOCATED WITH ANOTHER IMPLANT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19289708 ↗MalfunctionMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 05/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3671 FIBERTAK IMPLANTS PULLED OUT. THIS OCCURRED ON 05/10/2022 DURING A SHOULDER ARTHROSCOPY PROCEDURE WHEN THE SURGEON DRILLED WITH THE APPROPRIATE DRILL, HE THEN WENT TO ENGAGE THE IMPLANT AND IT PULLED OUT, THIS OCCURRED AGAIN WITH A SECOND IMPLANT. THE CASE WAS COMPLETED USING 2 AR-3670 FIBERTAKS, AND THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288930 ↗MalfunctionMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 05/10/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) (B)(6) FIBERTAK IMPLANTS PULLED OUT. THIS OCCURRED ON (B)(6) 2022 DURING A SHOULDER ARTHROSCOPY PROCEDURE WHEN THE SURGEON DRILLED WITH THE APPROPRIATE DRILL WENT TO ENGAGE THE IMPLANT AND IT PULLED OUT. THIS OCCURRED AGAIN WITH A SECOND IMPLANT. THE CASE WAS COMPLETED USING 2 (B)(6) FIBERTAKS, AND THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19252764 ↗MalfunctionMay 6, 2024Failure to Advance; Failure to Advance
ON 12/15/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3671 FIBERTAK ANCHOR WOULD NOT SEAT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON OPENED A NEW DEVICE AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES.
Patient problems: Insufficient Information
MAUDE report 19250167 ↗MalfunctionMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 09 APRIL 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ONE OF THE NEEDLES FELL OFF AN AR-3671 FIBERTAK BICEPS IMPLANT. THIS OCCURRED DURING A BICEPS TENODESIS PROCEDURE ON (B)(6) 2024 AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A MAYO NEEDLE. THERE WAS CASE AND PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 19220730 ↗MalfunctionOct 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT (2) AR-3632SP FIBERTAK SP, AND AN AR-3671 FIBERTAK BICEPS IMPLANT ANCHORS PULLED OUT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17963835 ↗MalfunctionAug 18, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE DEVICE GOT BENT DURING IMPLANTATION. 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 17576834 ↗MalfunctionJun 29, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224046 ↗MalfunctionDec 1, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3671 FIBERTAK BICEPS ANCHOR COULD NOT BE IMPLANTED BECAUSE THE INSERTER BROKE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15893223 ↗MalfunctionMar 29, 2021Break
IT WAS REPORTED THAT DURING A SHOULDER REPAIR, THE SUTURE TORE WHILE THE SURGEON WAS SETTING THE ANCHOR. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY SUING A NEW AR-3671 WITHOUT FURTHER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11585784 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.