Arthrex® AR-3519HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867266643), received between Oct 19, 2021 and Sep 2, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  It was reported that during an avascular necrosis surgery the blade tip snapped off during pushing up 5mm tunnel and was left in the bone. 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: Foreign Body In Patient

  MAUDE report 50567498 ↗
• MalfunctionMay 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  UPDATE (B)(6) 02-JUN-2025 FURTHER INFORMATION WAS RECEIVED THAT CLARIFIES THE ISSUE: AFTER INSERTING THE DRILL BIT THROUGH THE SLEEVE, THE SURGEON HAD A PROBLEM WITH THE CORRECT OPERATION OF THE BLADE. THE BLADE DID NOT OPEN PROPERLY. THE SURGEON HAD TROUBLE GETTING THE DRILL BIT OUT OF THE SLEEVE BUT EVENTUALLY SUCCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106749 ↗
• MalfunctionSep 23, 2024Break; Break

  ON 09/13/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT (B)(6) OF AN AR-3519H HIP AVN DISPOSABLES KIT HAD THE BACK PART THAT CONNECTS TO THE T-HANDLE BREAK OFF MID-CASE WHEN HE STARTED TO USE THE EXPANDABLE REAMER. A SECOND KIT WAS OPENED FROM THE SAME LOT AND THE SAME ISSUE OCCURRED. THEY BOTH BROKE VERY QUICKLY. THE SURGEON REAMED BY HAND TO COMPLETE THE CASE. 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 20278032 ↗
• MalfunctionSep 23, 2024Break; Break

  ON 09/13/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4). THAT (B)(4) OF AN AR-3519H HIP AVN DISPOSABLES KIT HAD THE BACK PART THAT CONNECTS TO THE T-HANDLE BREAK OFF MID-CASE WHEN HE STARTED TO USE THE EXPANDABLE REAMER. THEY BOTH BROKE VERY QUICKLY. THE SURGEON REAMED BY HAND TO COMPLETE THE CASE. 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 20277938 ↗
• InjuryJun 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 03/09/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3519H HIP AVN DISPOSABLES KIT HAD AN ISSUE, DEPLOYED EARLY AND FELL APART DURING THE CASE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON 03/09/2022, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA PHONE: DURING A HIP AVN PROCEDURE ON (B)(6) 2022, THE PORTABLE ARM OF THE REAMER DEPLOYED EARLY IN THE PATIENT AND THE DEPLOYMENT MECHANISM BROKE. THE WHOLE REAMER WITH THE DEPLOYED, STUCK PORTABLE ARM WAS REMOVED FROM THE PATIENT, AND NO PIECE BROKE OFF INSIDE THE PATIENT. ANOTHER REAMER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO CASE DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481738 ↗
• MalfunctionJun 5, 2024Fitting Problem; Fitting Problem

  ON 7/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT 2 PINS FELL OUT OF THE BLACK KNOB EXPANDABLE REAMER FROM AN AR-3519H HIP AVN DISPOSABLES KIT. AS SURGEON WAS INCREMENTALLY OPENING THE REAMER, THERE WAS NOT CLICK AND THE BLADE COULD NOT BE SEEN OPENING UNDER FLUOROSCOPY. AS SURGEON STARTED TO OPEN FROM A 6, 1-2 CLICK AT A TIME UNTIL THERE WAS NO RESISTANCE. BY THE TIME SURGEON REACHED A 9, 2 PINS FELL OFF THE HANDLE ON THE FLOOR AND ONLY ONE COULD BE FOUND. SURGEON USED ANOTHER EXPANDABLE REAMER TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 7/27/2022: THIS WAS DISCOVERED DURING AN INTRAOSSEOUS BIOPLASTY OF HIP WITH EXPANDABLE REAMER. BMC + ALLOSYNC PURE PROCEUDRE ON (B)(6) 2022. CASE WAS COMPLETED USING ANOTHER AR-3519H HIP AVN DISPOSABLES KIT WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469659 ↗
• MalfunctionJun 2, 2024Break; Break

  ON 10/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-3519H HIP AVN DISPOSABLES KIT WHERE THE BLACK KNOB TURNS, THE METAL PIECE LOOKS LIKE IT SNAPPED OFF. THIS OCCURRED DURING AN UNKNOWN CASE THEY WEREN'T ABLE TO KEEP EXPANDING AND REAMING DURING USE. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444627 ↗
• MalfunctionMay 8, 2024Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06541210 THAT AN AR-3519H HIP AVN DISPOSABLES KITS EXPANDABLE REAMER WOULD NOT BE EXPANDED. THIS OCCURRED DURING A HIP CORE DECOMPRESSION THEY HAD MADE IT THROUGH ALMOST THE ENTIRETY OF THE CASE, AND THEN WHEN THE SURGEON TRIED TO EXPAND THE REAMER INSIDE THE PATIENT, IT WOULD NOT EXPAND. THE CASE WAS COMPLETED USING ANOTHER KIT.

  Patient problems: Insufficient Information

  MAUDE report 19274586 ↗
• MalfunctionMar 22, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING AN HIP AVASCULAR NECROSIS (AVN) SURGERY WITH BMAC AND INNOTERE THE BLADE DEPLOYED WHEN IT WAS NOT SUPPOSED TO. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (5 MM REAMER). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 13-MAR-2024 IT WAS CONFIRMED THAT THE BLADE PUSHED OUT EVERY TIME THE SURGEON PUT PRESSURE ON THE BACK OF THE DEVICE. IT WAS DIFFICULT TO ADVANCE THE DEVICE WITHOUT PLACING PRESSURE ON THE BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960417 ↗
• MalfunctionDec 28, 2023Break; Break

  ON 12/1/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BLADE FROM AN AR-3519H HIP AVN DISPOSABLES KIT, DEPLOYED PREMATURELY AND BROKE OFF INSIDE THE PATIENT. THE BROKEN FRAGMENTS WERE NOT REMOVED. THE CASE WAS COMPLETED USING A DIFFERENT SET OF REAMERS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 12/6/2023: THIS WAS DISCOVERED DURING A TREATMENT FOR A BONE LESION OF THE FEMORAL HEAD PROCEDURE, AND THE CASE WAS COMPLETED WITH A PRODUCT FROM ANOTHER MANUFACTURER. THE CASE WAS DELAYED FOR ATTEMPTING TO REMOVE THE REAMING AND LOCATE A NEW REAMER THAT WOULD BE LONG ENOUGH TO COMPLETE THE PROCESS. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE SALES REPRESENTATIVE KNOWLEDGE, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18409958 ↗
• MalfunctionMar 14, 2022Break; Entrapment of Device

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH LETTER THAT AN AR-3519H HIP AVN DISPOSABLES KIT DRILL PIN BOKE OFF IN PATIENTS BONE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13757293 ↗
• InjuryDec 27, 2021Retraction Problem; Output Problem; Activation Failure

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT DURING USE OF AN AR-3519H KIT, THE SURGEON WAS INSERTING THE REAMER INTO THE FEMORAL TUNNEL, THE BLADE DEPLOYED HALFWAY OF THE INTENDED DISTANCE, AND WOULD NOT RETRACT. THE SURGEON REMOVED THE REAMER, WITH THE BLADE DEPLOYED. THIS WAS DISCOVERED DURING USE IN A AVN SURGICAL PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED OPENING A NEW AR-3519H. ADDITIONAL INFORMATION: 12/08/2021 ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT DURING USE OF AN AR-3519H KIT, THE SURGEON WAS INSERTING THE REAMER INTO THE FEMORAL TUNNEL, THE INTENDED SOCKET SIZE AT THAT PART OF THE CASE WAS A 5MM TUNNEL. THE BLADE WAS DEPLOYED ALL THE WAY OUT TO 15 CREATING A TROUGH IN THE TUNNEL THAT WAS NOT INTENDED. THIS ISSUE PROBABLY ADDED 20 MIN TO THE CASE SINCE WE HAD TO RE-POSITION THE GUIDE TO CREATE A NEW BONE TUNNEL PATH. NO ADDITIONAL INCISIONS WERE MADE.

  Patient problems: Insufficient Information

  MAUDE report 13087959 ↗
• MalfunctionOct 19, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3519H AVN DEPOSABLE KIT BROKE. THE SURGEON WAS INJECTING THE ALLOSYNC, AND THE NOZZLE OF THE SYRINGE BROKE OFF INSIDE THE CANNULA. ALL PIECES WERE REMOVED FROM THE PATIENT. THIS WAS DISCOVERED DURING USE IN A HIP ARTHROSCOPY ON (B)(6) 2021. THE CASE WAS COMPLETED BY OPENING A NEW AR-3519H.

  Patient problems: Insufficient Information

  MAUDE report 12659579 ↗