Arthrex® AR-3638DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867287433), received between Nov 4, 2020 and Jan 12, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Device Markings/Labelling Problem; Missing Information

  ON 18-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3638DC FIBERTAK HAD NO LASER MARKING ON THE TIP OF THE DRILL GUIDE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED USING ANOTHER PRODUCT FROM A DIFFERENT LOT. NO PHOTO WAS PROVIDED. NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035663 ↗
• MalfunctionJan 12, 2026Physical Resistance/Sticking

  ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-3638DC CURVED KNOTLESS FIBERTAK DISPOABLE KIT JAMMED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035634 ↗
• MalfunctionAug 25, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DC FIBERTAK DISPOSABLE CURVED KIT DRILL DID NOT FIT PROPERLY IN DRILL GUIDE. THE SURGEON STATED THAT IT FELT TIGHTER DOWN THE DRILL GUIDE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885411 ↗
• InjuryJun 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 22ND MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-3638DC, KNOTLESS FIBERTAK¿ DISPOSABLE KIT, CURVED, WHEN THE SURGEON USED DRILL GUIDE AND DRILL BIT FROM AR-3638DC TO REPAIR CAPSULE DURING LATARJET PROCEDURE, HE ENCOUNTERED SOME RESISTANCE BUT EVENTUALLY WAS ABLE TO IMPLANT THE ANCHOR AND CONVERT THE KNOTLESS MECHANISM. THIS WAS DETECTED DURING A LATARJET PROCEDURE ON (B)(6) 2025. PROCEDURE WAS COMPLETED SUCCESSFULLY AS NORMAL. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THE BROKEN DRILL BIT IS IDENTIFIED IN WHITE. DRILL BIT IS YET TO BE RETRIEVED BUT WILL BE SOON. PATIENT WILL NEED TO BE REVISED TO REMOVE THE DRILL BIT. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND IT WAS DETERMINED TO BE AR-3636 LOT NUMBER 15371028. THIS WAS DETERMINED ONLY DURING THE PROCEDURE TO REMOVE THE BROKEN PART. IT WAS FURTHER CLARIFIED THAT AR-3636 LOT NUMBER 15371028 WAS ALSO USED IN THE ORIGINAL LATERJET PROCEDURE AND IT TURNED OUT THAT IT WAS THE DEVICE THAT BROKE AS IT WAS ONLY DETERMINED UPON REVISION PROCEDURE AND REMOVAL.

  Patient problems: Insufficient Information

  MAUDE report 22224901 ↗
• MalfunctionJun 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3600-2 FIBERTAK SUTURE ANCHOR AND AN AR-3638DC KNOTLESS FIBERTAK DISPOSABLE KIT, CURVED HAD AN ISSUE DURING A SHOULDER ROTATOR CUFF REPAIR PROCEDURE WITH BICEPS TENODESIS ON (B)(6) 2024. THE SURGEON PUT THE DRILL GUIDE ON, DRILLED AND INSERTED THE SUTURE ANCHOR THROUGH THE DRILL GUIDE, WHEN A PLASTIC PART OF THE ANCHOR INSERTER THAT WAS OUTSIDE OF THE PATIENT BROKE OFF INSIDE THE DRILL GUIDE. THE INSERTER COULD NOT BE REMOVED FROM THE DRILL GUIDE, THEY HAD FUSED TOGETHER. WHEN REMOVING THE INSERTER TOGETHER WITH THE DRILL GUIDE FROM THE PATIENT, THE KNOTLESS SUTURE ANCHOR WAS PULLED OUT AS WELL. NOTHING BROKE OFF INSIDE THE PATIENT, THE BROKEN PLASTIC PIECE WAS CONTAINED WITHIN THE DRILL GUIDE AND EVERYTHING WAS REMOVED. THE SAME SPOT WAS USED, THE HOLE WAS MADE BIGGER AND AN AR-1927PSF-475 SUTURE ANCHOR, PEEK CORKSCREW FT WITH AN UNKNOWN LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICES WERE DISCARDED, BUT PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614139 ↗
• MalfunctionJun 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 15 APRIL 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THERE HAD BEEN AN INCIDENT WITH AN AR-3638DC FIBERTAK DISPOSABLES CURVED KIT. THIS OCCURRED DURING A SHOULDER STABILISATION IN (B)(6) HOSPITAL ON (B)(6) 2024. THE SURGEON DRILLED THE PILOT HOLE USING THE DRILL AND DRILL GUIDE FROM THE PACK. WHEN THE ANCHOR WAS BEING INSERTED THE SLEEVE DID NOT ALLOW THE ANCHOR TO SLIDE IN. A SECOND ANCHOR WAS OPENED AND HAD THE SAME ISSUE. A NEW DRILL GUIDE PACK WAS OPENED AND THIS WORKED AND ALLOWED THE CASE TO BE COMPLETED SUCCESSFULLY. THERE WAS CASE/PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19497990 ↗
• MalfunctionMay 14, 2024

  ARTHREX 1.8 KNOTLESS FIBER TAK SOFT ANCHOR IMPLANTED IN LEFT SHOULDER. THE ANCHOR INSERTER WAS VISUALLY INSPECTED UPON WITHDRAWAL. IT WAS NOTED THAT THE TWO PRONGS AT THE TIP OF THE INSERTER HAD BROKEN OFF AND REMAINED IMBEDDED IN THE BONE. ANOTHER 1.8 KNOTLESS FIBER TAK SOFT ANCHOR WAS INSERTED, AND THE SAME SITUATION OCCURRED. BOTH ANCHORS HAD A LOT# OF 15104066 TO COMPLETE SURGERY ABOVE LOT # ANCHORS REMOVED AND ANOTHER LOT # OF ARTHREX ANCHORS USED WITHOUT INCIDENT. SURGERY WAS COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19309755 ↗
• MalfunctionMay 6, 2024Defective Device; Defective Device

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3638DC DRILL GUIDE WOULD NOT ALLOW DRILL BIT DO BORE DEEP ENOUGH FOR FULL INSERTION OF THE AR-3636 FIBERTAK, THEREFORE FIBERTAK PULLED OUT . CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19251224 ↗
• InjuryNov 10, 2023Defective Device; Defective Device

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT 3X AR-3636 FIBERTAK IMPLANTS WERE INSERTED. THE FIRST IMPLANT SEATED CORRECTLY. THE SECOND AND THIRD IMPLANT HAD TO BE MALLETED A SECOND TIME TO FULLY INSERT. AFTER REMOVING THE INSERTER THE TIP WAS DISCOVERED BROKEN. SURGERY WAS COMPLETED WITHOUT ISSUE. ON (B)(6) 2023 X-RAYS WERE TAKEN TO LOCATE BROKEN INSERTER PIECES. REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2023 TO REMOVE BROKEN INSERTER PIECES. IN THE SAME CASE, AN AR-3638DC DRILL GUIDE IS SUSPECTED TO BE THE CAUSE OF THE ANCHOR MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 18115910 ↗
• MalfunctionMay 9, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3638DC FIBERTAK TIP BROKE OFF IN A PATIENT DURING AN UNKNOWN PROCEDURE. THIS WAS DISCOVERED 2 WEEKS POST OP WHEN AN X-RAY WAS TAKEN AT THE FACILITY AND A FRAGMENT WAS DISCOVERED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14337585 ↗
• InjuryNov 4, 2020Entrapment of Device

  IT WAS REPORTED THAT WHILE PERFORMING A (B)(6) 2020 INFERIOR ANTERIOR AND POSTERIOR LABRAL REPAIR OF A LEFT SHOULDER, THE SURGEON DECIDED TO USE A KNOTLESS FIBERTAK (AR-3638) TO ACCESS THE 5 O'CLOCK POSITION (LOW ANTERIOR) OF THE GLENOID. A KNOTLESS FIBERTAK HAD ALREADY BEEN PLACED AT THE INFERIOR-MOST ASPECT OF THE GLENOID. THE DRILL GUIDE (AR-3638DC) WAS PLACED THROUGH THE ANTERIOR PORTAL ONTO THE LOW ANTERIOR GLENOID RIM. THE DRILL GUIDE WAS GENTLY TAPPED WITH A MALLET TO SEAT IT ON THE RIM. THE APPROPRIATE KNOTLESS FIBERTAK DRILL BIT WAS INSERTED INTO THE DRILL GUIDE AND DRILLED INTO THE GLENOID. THE SURGEON OBSERVED THAT THE BONE FELT "VERY HARD" AS THE DRILL WAS BEING ADVANCED. THE DRILLING WAS COMPLETED AND THE DRILL WAS REMOVED. THE ANCHOR WAS THEN INSERTED DOWN THE DRILL GUIDE AND MALLETED INTO THE SOCKET. WHEN THE KNOTLESS FIBERTAK INSERTER WAS GENTLY TUGGED ON TO SET THE ANCHOR, THE ANCHOR EXPLANTED FROM THE SOCKET IN ITS ENTIRETY. A KNOTLESS SUTURETAK (AR-1938BC) WAS USED ADJACENT TO THE KNOTLESS FIBERTAK POSITION, JUST SLIGHTLY SUPERIOR. NO CONCERNS WERE NOTED OR ADDRESSED AT THE TIME OF SURGERY. TWO WEEK POST OPERATIVE X-RAY IMAGES SHOWED A METALLIC OBJECT IN THE LOW

  Patient problems: Foreign Body In Patient

  MAUDE report 10785825 ↗