Arthrex® AR-4005B-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867031166), received between Jun 30, 2017 and Feb 13, 2026 — classified as 3 injuries, 13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT DURING A CHONDRAL DARTS PROCEDURE THE ARROW BROKE DURING INSERTION IN THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER 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 24337761 ↗
• MalfunctionMay 9, 2025Break; Break

  ON 04/10/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-4005B-18 CHONDRAL DART RUPTURED INSIDE THE PATIENT. THE CASE WAS COMPLETED WITH THE PLACEMENT OF ADDITIONAL IMPLANTS. NO FURTHER DETAILS WERE PROVIDED. THIS OCCURRED DURING AN OSTEOCHONDRAL FLAP FIXATION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21992824 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER THE DEVICE WAS IMPLANTED INTO THE CARTILAGE IT FELL OUT. PER COMPLAINT REPORTER 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 21773342 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER THE DEVICE WAS IMPLANTED INTO THE CARTILAGE IT FELL OUT. PER COMPLAINT REPORTER 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 21773340 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER THE DEVICE WAS IMPLANTED INTO THE CARTILAGE IT FELL OUT. PER COMPLAINT REPORTER 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 21773339 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER THE DEVICE WAS IMPLANTED INTO THE CARTILAGE IT FELL OUT. PER COMPLAINT REPORTER 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 21773336 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER THE DEVICE WAS IMPLANTED INTO THE CARTILAGE IT FELL OUT. PER COMPLAINT REPORTER 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 21773335 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER THE DEVICE WAS IMPLANTED INTO THE CARTILAGE IT FELL OUT. PER COMPLAINT REPORTER 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 21773333 ↗
• MalfunctionApr 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY AFTER THE DEVICE WAS IMPLANTED INTO THE CARTILAGE IT FELL OUT. PER COMPLAINT REPORTER 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 21773329 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A CHONDRAL FLAP REPAIR SURGERY THE CHONDRAL DART BROKE. PER COMPLAINT REPORTER 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 21305511 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A CHONDRAL FLAP REPAIR SURGERY THE CHONDRAL DART BROKE. PER COMPLAINT REPORTER 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 21305360 ↗
• MalfunctionJun 7, 2024Break; Break

  ON 5/08/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4005B-18 CHONDRAL DART BROKE. THIS OCCURRED DURING A PROCEDURE WHERE THE CHONDRAL DART BROKE WHILE INSERTED INTO THE DEFECT. A SECOND ONE WAS IMPLANTED SUCCESSFULLY. NOTHING WAS LEFT INSIDE THE PATIENT.ADDITIONAL INFORMATION WAS PROVIDED ON 05/14/2024 WHERE THE SALES REPRESENTATIVE STATED THIS EVENT OCCURRED DURING A FEMORAL CONDYLE OCD THE DRILL FOR THE DART IN THE KIT WAS USED TO PREPARE THE BONE. THE PATIENT HAD A HARD BONE. ALL FRAGMENTS WERE RETRIEVED, AND A SECOND CHONDRAL DART WAS USED TO PROCEED WITH THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19481946 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A CHONDRAL DART SURGERY AN ATTEMPT WAS MADE TO FIX A FLAKE FRACTURE WITH THREE DARTS. ALL THREE DARTS BROKE OFF DURING INSERTION, ALTHOUGH THE PROCEDURE WAS EXACTLY AS DESCRIBED IN THE OPERATION INSTRUCTION. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE FLAKE FRACTURE WAS FIXED SUCCESSFULLY WITH 1,5MM SCREWS BY ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931321 ↗
• InjuryJul 5, 2022Break; Defective Device; Mechanical Jam; Positioning Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-4005B-18 CHONDRAL DART WOULD NOT SEAT. SURGEON STARTED WITH THE MULTI-USE GUIDE AND INSERTED ALL 4 DRILL PINS. THEN THE FIRST DRILL PIN WAS PULLED AND INSERTED GUIDE, IMPLANT, AND STARTED IMPACTING GENTLY. IMPLANT PUSH ROD WOULD NOT SEAT FULLY. SURGEON PULLED IMPLANT INSERTER OUT TO SEE CHONDRAL DART WAS COMPACTED AND JAMMED IN INSERTER. A SINGLE SHOT GUIDE WAS OPENED TO GET ANOTHER INSERTER. SURGEON PROCEEDED TO PULL ADDITIONAL DRILL PINS TO TRY NEW HOLES. TWO OF THESE DRILL PINS CAME OUT OF THE GUIDE WITH BROKEN TIPS. IMPLANTS CONTINUED NOT TO SEAT ALL THE WAY AND STAY MID-SUBSTANCE INSIDE CHONDRAL FLAP. EVENTUALLY, SURGEON BAILED OUT TO JUST A SINGLE SHOT GUIDE AND WAS VERY CAREFUL WITH HOLDING THE GUIDE STILL, CYCLING THE DRILL 3-4 TIMES, AND GENTLY TAPPING THE DART IN PLACE. THIS ONE LOOKED PERFECT, BUT WHEN THE GUIDE WAS LIFTED, THE FLAP LIFTED OFF THE BONY SURFACE. UPON INSPECTION, THE BACK SIDE OF THE CHONDRAL DEFECT HAD EXPOSED CHONDRAL DARTS AND BOTH DRILL TIPS. SURGEON WAS ABLE TO RETRIEVE ALL DARTS AND DRILL TIPS WITH AN ARTHROSCOPIC GRASPER. SURGEON SPECULATED THAT THE DRILL BIT WAS FULLY PU

  Patient problems: Insufficient Information

  MAUDE report 14914561 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT KNEE REPAIR ON (B)(6) THE PATIENT WAS DIAGNOSED WITH AN INFECTION. ADDITIONAL INFORMATION OBTAINED (B)(6) 2017: PROCEDURE WAS TO CORRECT A RIGHT OSTEOCHONDRAL DEFECT. THE FOLLOWING DEVICES WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE: BIOCARTILAGE 1CC, ABS-1010-BC, LOT: 014075 (QTY1) (CC127520 LINE 210231) AND CHONDRAL DART 18MM, AR-4005B-18, LOT: E1616 (QTY 3) (CC127520 LINE 211573). ADDITIONAL INFORMATION OBTAINED (B)(6) 2017: TYPE OF SURGERY: RIGHT KNEE ARTHROSCOPY, DRILLING AND PINNING OF OSTEOCHONDRAL LESION, INSERTION OF BIOCARTILAGE TO FILL CARTILAGE GAP DUE TO OSTEOCHONDRAL LESION. HARVEST OF CARTILAGE FOR POTENTIAL MACI GRAFT IN FUTURE. OPEN EXCISION OF SYMPTOMATIC FRAGMENT OF TIBIAL TUBERCLE AS SEQUELA OF PREVIOUS OSGOOD-SCHLATTER DISEASE, THROUGH SEPARATE INCISION. SURGEON REPORTED THAT PATIENT WAS ADMITTED TO ANOTHER FACILITY ON (B)(6) 2017. ADDITIONAL INFORMATION OBTAINED (B)(6) 2017: PATIENT HAS BEEN EXPERIENCING A FEVER READING 103 WITH ELEVATED PAIN AND SWELLING WHICH BEGAN 3 DAYS POST OP. PATIENT IS (B)(6) FROM KNEE JOINT.

  Patient problems: Fever; Pain; Swelling; Unspecified Infection

  MAUDE report 7033765 ↗
• InjuryJun 30, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A CASE, THE SURGEON WAS USING CHONDRAL DARTS TO FIXATE A CHONDRAL DEFECT. A SMALL PIECE OF THE 18 MM ARTHREX CHONDRAL DART, AR-4005B-18, LOT: E3329, BROKE-OFF DURING INSERTION. THE FRAGMENT WAS RETRIEVED AND DISCARDED. THE MAJORITY OF THE IMPLANT WAS PURPOSELY LEFT IN THE PATIENT FOR ADDITIONAL FIXATION, AS THERE WERE ENOUGH BARBS TO PROVIDE SAID FIXATION. ADDITIONAL DARTS WERE USED AS PRESCRIBED FOR ADDITIONAL FIXATION. THIS DID NOT CAUSE AN ADVERSE EFFECT TO THE PATIENT, AND NO INTERVENTION WAS NECESSARY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6680675 ↗