Arthrex® AR-3610PK-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00888867358225), received between Feb 21, 2022 and Mar 6, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Physical Resistance/Sticking

  ON 13-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3610PK-3 FIBERTAK INSERTION KIT DRILL BIT WAS COLD-WELDING TO THE DRILL GUIDE UPON THE FIRST ATTEMPT TO DRILL. IT WAS USED TO COMPLETE THE CASE WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531870 ↗
• MalfunctionMar 6, 2026Physical Resistance/Sticking

  ON 13-FEB-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3610PK-3 FIBERTAK INSERTION KIT DRILL BIT WAS COLD-WELDING TO THE DRILL GUIDE UPON THE FIRST ATTEMPT TO DRILL. IT WAS USED TO COMPLETE THE CASE WITH NO PATIENT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531849 ↗
• MalfunctionFeb 20, 2026Physical Resistance/Sticking

  ON 04-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-3610PK-3 1.8MM PERC INSERT KIT FOR FIBERTAK EXPERIENCED AN ISSUE WHEN ATTEMPTING TO DO A POSTERIOR PERC LABRAL REPAIR, BUT THE SWITCHING STICK FROM THE KIT WOULD NOT SLIDE OVER THE GUIDEWIRE. THE SURGEON THEN REMOVED THE WIRE FROM THE SHOULDER AND TRIED TO PASS THE GUIDEWIRE THROUGH THE SWITCHING STICK AGAIN. IT WOULD ONLY GO IN ABOUT 25% OF THE WAY BEFORE IT WOULD STOP. THE SURGEON ATTEMPTED TO USE FORCE TO PASS IT THROUGH TO NO AVAIL. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401326 ↗
• MalfunctionDec 3, 2025Break; Break

  ON 11/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3610PK-3 PERC INSERT KIT DRILL BIT BROKE OFF DEEP INSIDE THE GLENOID AFTER DRILLING AND INSERTING THE FIRST ANCHOR. THIS OCCURRED DURING USE IN A LABRAL REPAIR CASE.

  Patient problems: Insufficient Information

  MAUDE report 23704874 ↗
• MalfunctionMay 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT 3 AR-3610PK-3 PERK KITS DRILL BITS ARE WELDING TO THE SHAFT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116709 ↗
• MalfunctionMay 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT 3 AR-3610PK-3 PERK KITS DRILL BITS ARE WELDING TO THE SHAFT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116700 ↗
• MalfunctionMay 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT 3 AR-3610PK-3 PERK KITS DRILL BITS ARE WELDING TO THE SHAFT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116698 ↗
• MalfunctionFeb 26, 2025Break; Break

  ON 18 FEBRUARY 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3610PK-3, 1.8MM PERC INSERT KIT FOR FIBERTAK WAS REPORTED TO HAVE SNAPPED DURING USE. THIS OCCURRED ON (B)(6) 2025 IN (B)(6) DURING AN UNKNOWN PROCEDURE. IT WAS REMOVED FROM THE PATIENT AND ANOTHER KIT WAS OPENED TO BE ABLE TO PROCEED WITH THE PROCEDURE THE CASE WAS COMPLETED SUCCESSFULLY USING A NEW KIT. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21470140 ↗
• MalfunctionFeb 5, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3610PK-3 FIBERTAK, PERCUTANEOUS INSERTION KIT, HAD THE DRILL BREAK WHEN IN USE IN THE PATIENT. THEY WERE NOT ABLE TO REMOVE THE BROKEN PIECE FROM THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 01/21/2025: THE CASE WAS COMPLETED USING A DISPOSABLE FLEXIBLE 1.8 DRILL. THE TECHNIQUE WAS NOT CHANGED, AND THERE WAS NO UNPLANNED INCISION DUE TO THE ISSUE. THERE WAS NO CASE DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THERE IS NO REVISION SURGERY TO REMOVE THE BROKEN FRAGMENT FROM THE PATIENT SCHEDULED. NO MEDICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF THE PATIENT IS EXPERIENCING A REDUCED QUALITY OF LIFE DUE TO THE DEVIATION. THIS OCCURRED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 21314081 ↗
• MalfunctionJan 8, 2025Failure to Advance; Failure to Advance

  ON 12/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3610PK-3 FIBERTAK PERCUTANEOUS INSERTION KIT HAD A SWITCHING STICK NOT FULLY CANNULATED AND THE NITINOL WIRE COULD NOT ADVANCE. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21102742 ↗
• MalfunctionNov 25, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 10/31/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3610PK-3 PERCUTANEOUS INSERTION KIT FOR KNOTLESS FIBERTAK ANCHOR DRILL SLEEVE WAS BENT. ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITHOUT ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774659 ↗
• MalfunctionNov 12, 2024Fitting Problem; Fitting Problem

  ON 11/04/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06703050 THAT AN AR-3610PK-3 FIBERTAK DILATATIR WAS NOT PROPERLY CANULATED SO THE GUIDE PIN WAS NOT GOING THROUGH. THIS OCCURRED DURING A REMPLISSAGD PROCEDURE ON (B)(6) 2024 WHERE ANOTHER KIT WAS OPENED TO PROCEED WITH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665814 ↗
• MalfunctionAug 28, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 08/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-3610PK-3 PERCUTANEOUS INSERTION KIT FOR KNOTLESS FIBERTAK ANCHOR HAD THE DRILL SPOT-WELDED WITH THE GUIDE WHEN USED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08/08/2024: THIS WAS DISCOVERED DURING A SHOULDER SCOPE, LABRAL REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED BY USING A STRAIGHT GUIDE FIBERTAK DISPOSABLE KIT INSTEAD OF THE FAULTY 1.8 FIBERTAK PERCUTANEOUS KIT. THERE WAS NO CASE DELAY REPORTED AND NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20086197 ↗
• MalfunctionJul 1, 2024Break; Break

  ON 6/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3610PK-3 FIBERTAK, PERCUTANEOUS INSERTION KIT HAD A DRILL BREAK AT THE TIP DURING USE. THE TIP WAS NOT RETRIEVED FROM THE PATIENT. THE STANDARD TECHNIQUE WAS BEING USED IN HARD BONE. THE DRILL TIP BROKE ON THE LAST ANCHOR HOLE AND WAS NOT NEEDED FOR THE REST OF THE CASE. THE ANCHOR DEPLOYED AND FIRMLY HELD IN THE HOLE. THERE WAS NO DELAY TO THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19644882 ↗
• MalfunctionMay 24, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 2/3/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3610PK-3 1.8MM INSERT KIT FOR FIBERTAK IS NOT FULLY CANNULATED. THIS WAS DISCOVERED DURING A GLENOID LABRAL REPAIR. THE DOCTOR TRIED TO PLACE THE DRILL THROUGH THE GUIDE BUT COULD NOT. ANOTHER GUIDE WAS OPENED TO COMPLETE THE PROCEDURE. DURING INSPECTION AFTER THE CASE IT WAS DISCOVERED THE GUIDE WAS NOT EVEN ABLE TO FIT A 1.1MM WIRE. THE GUIDE DID NOT APPEAR TO BE FULLY STRAIGHT AND HAD A SLIGHT BEND TO IT. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390516 ↗
• MalfunctionFeb 29, 2024Material Fragmentation; Material Fragmentation

  ON 13TH FEBRUARY 2024, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT FOR AN AR-3610PK-3, FIBERTAK®, PERCUTANEOUS INSERTION KIT, THE SURGEON WHO REGULARLY USED THE 1.8 KNOTLESS FIBERTAK PERCUTANEOUS DRILL KIT, WHEN HE TRIED TO PLACE THE SWITCHING STICK DOWN THE DRILL SLEEVE, THERE WAS AN ITEM BLOCKING IT. THIS DRILL SLEEVE HAD JUST COME OUT OF THE DISPOSABLE KIT AND HAD NOT BEEN USED PRIOR. ON FURTHER INSPECTION THE SCRUB NURSE INSERTED THE SWITCHING STICK INTO THE DRILL GUIDE AND A METAL SHAVING CAME OUT OF THE DRILL GUIDE. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REUSABLE DRILL GUIDE. THE DRILL SLEEVE WAS USED AND THEN DISCARDED. THE SALES REP. DOES HAVE THE METAL SHAVINGS THAT WERE FORCED OUT OF THE DRILL GUIDE. 22ND FEBRUARY 2024 - THE SALES REP. RESPONDED THAT THE MALFUNCTIONING DRILL GUIDE WAS USED ONCE THE BLOCKAGE WAS CLEARED, THE REUSABLE GUIDE THEY HAD ON CONSIGNMENT WAS USED FOR THE FIRST TWO ANCHORS. THIS WAS SLOTTED, SO IT DID CAUSE ISSUES WITH SUTURE MANAGEMENT, HENCE THE DISPOSABLE WAS USED FOR THE FINAL ANCHOR.

  Patient problems: Insufficient Information

  MAUDE report 18810636 ↗
• MalfunctionFeb 19, 2024Break; Break

  ON 1/29/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3610PK-3 FIBERTAK, PERCUTANEOUS INSERTION KIT, AND AN AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHOR HAD BREAKAGE DURING USE. WHEN THE AR-3610PK-3 FIBERTAK DRILL BIT WAS 2CM IN, THE END BROKE OFF IN THE TUNNEL AND COULD NOT BE RETRIEVED. AN X-RAY WAS TAKEN, AND THEY COULD NOT FIND THE BROKEN PIECE IN THE PATIENT. IT WAS STATED THAT IT WAS CONTAINED IN THE TUNNEL, NOT THE PATIENT. WHILE IMPLANTING THE AR-3636 KNOTLESS 1.8 FIBERTAK SOFT ANCHOR, THE SURGEON HAD A HARD TIME WITH IMPLANTATION, AND WHEN REMOVING THE INSERTER FOR THE ANCHOR WHERE IT WAS HELD, IT BROKE OFF. THE CASE WAS COMPLETED USING FOUR MORE ANCHORS OF THE AR-3636 FROM THE SAME LOT WITH NO ISSUES. THE CASE WAS DELAYED A FEW MINUTES, AND NO REPORTED ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING A SHOULDER LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18730793 ↗
• MalfunctionNov 3, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3610PK-3, 1.8MM PERC INSERT KIT FOR FIBERTAK, DRILL BIT BROKE. THIS OCCURRED DURING RIGHT WRIST ARTHROSCOPY AND TFCC REPAIR ON (B)(6) 2023. FIBERTAK PERCUTANEOUS INSERTION KIT WAS OPENED AND LOADED IN CHUCK ATTACHMENT. IT JAMMED UP IN TROCAR IN KIT AND THE END IN THE CHUCK BROKE BETWEEN THE CHUCK AND BUMPER (SEE PHOTO). PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM BY OPENING AND USING ANOTHER IDENTICAL AND NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066734 ↗
• MalfunctionOct 31, 2023Break; Break

  ON 10/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-AR-3610PK-3 FIBERTAK HAD A DRILL BIT BREAK WHEN IMPLANTED IN THE BONE. THE BROKEN DRILL BIT WAS NOT RETRIEVED FROM THE PATIENT. THE SURGEON IMPLANTED TWO ANCHORS BEFORE THE THIRD BROKE. THE CASE WAS COMPLETED BY ABANDONING THE DRILL, AND NO FURTHER ANCHORS NEEDED TO BE IMPLANTED, WITH A 20-MINUTE REPORTED DELAY IN THE PROCEDURE TO IDENTIFY THAT THE DRILL BIT DID BREAK. THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING A HIP SCOPE LABRAL REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 18038279 ↗
• InjuryApr 4, 2022Entrapment of Device

  ON 3/16/2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH MAILED IN LETTER THAT A FRAGMENT OF SILVER METAL, PART OF THE FIBERTAK PERCUTANEOUS INSERTION KIT, AR-3610PK-3, WAS LEFT INSIDE THE PATIENT'S DURING A RIGHT SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022. THIS WAS DISCOVERED AFTER A FOLLOW UP X-RAY, DUE TO PATIENT COMPLAINT OF RIGHT SHOULDER PAIN, RELATED TO TRAUMA. THE DECISION WAS MADE TO OPERATE, REMOVE THE PIECE, AND ALSO REPAIR NEW TISSUE INJURY FROM RELATED TRAUMA. THIS PROCEDURE WAS A REMOVAL HARDWARE POSTERIOR GLENOID, REPAIR OF POSTERIOR LABRUM AND REPAIR NEW TEAR ANTERIOR LABRUM WITH FLUOROSCOPIC ASSISTANCE. DATE OF REVISION SURGERY IS UNKNOWN, NO FURTHER INFORMATION HAS BEEN GIVEN AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Laceration(s); Pain

  MAUDE report 13994945 ↗
• MalfunctionFeb 21, 2022Break

  ON(B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3610PK-3 FIBERTAK KIT HAD AN ISSUE WITH THE DRILL. DURING A LABRAL REPAIR THE DRILL BROKE INSIDE THE PATIENT ON IT'S FIRST USE. THE BROKEN PIECE WAS RETRIEVED AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13569738 ↗