Arthrex® AR-8655-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867044296), received between Jan 13, 2017 and Dec 23, 2025 — classified as 8 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Break; Break

  ON 12/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8655-06 CHONDRAL PICK TIP BROKE INTO ANKLE ARTICULATION. SURGERY WAS DELAYED RETRIEVING THE BROKEN TIP. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878448 ↗
• MalfunctionFeb 18, 2025Break; Break

  ON 01/30/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-8655-06 CHONDRAL PICK BROKE. THIS OCCURRED DURING USE WHEN THE TIP OF THE INSTRUMENT BROKE OFF INTO THE BONE.

  Patient problems: Insufficient Information

  MAUDE report 21392588 ↗
• MalfunctionJan 8, 2025Break; Break

  ON 12/11/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8655-06 CHONDRAL PICK ANKLE ATHROSCOPY HAD PART OF THE SET BREAK OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102626 ↗
• MalfunctionOct 28, 2024Break; Break

  ON 09/30/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-8655-06 CHONDRAL PICK, ANKLE ARTHROSCOPY, 60 DEGREE HAD THE TIP BREAK INSIDE THE PATIENT (SEE PHOTO ATTACHMENT). THE CASE WAS DELAYED 15 MINUTES FOR THE SURGEON TO RETRIEVE THE BROKEN PIECE IN THE ANKLE. 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 20547090 ↗
• MalfunctionSep 18, 2024Break; Break

  ON 08/29/2024, A SALES REPRESENTATIVE VIA SEMS-(B)(6) REPORTED THAT AN AR-8655-06 CHONDRAL PICK HAD THE TIP OF THE CHONDRAL PICK BREAK OFF DURING USE INSIDE THE PATIENT. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A MICROFRACTURE PROCEDURE OF AN OSTEOCHONDRAL LESION OF THE TALUS ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 09/03/2024: THERE WAS A CASE DELAY OF 10 MINUTES WHILE THE ATTENDING RETRIEVED THE BROKEN PIECE WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THE CASE WAS COMPLETED USING OTHER CHONDRAL PICKS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248306 ↗
• MalfunctionJun 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PER LOAN / CONSIGNMENT INSPECTIONS OPERATOR: THE HANDLE IS LOOSE ON THE SHANK. THE DEVICE WAS SENT IN WITHOUT ANY CUSTOMER ALLEGATION. THE PROBLEM WAS NOTICED AFTER THE SURGERY. THERE WAS NO HARM OR ADVERSE EVENT REPORTED BY THE CUSTOMER. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489807 ↗
• MalfunctionMar 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY THE TIP OF THE DEVICE BROKE OFF INTEROPERABILITY. IT WAS FURTHER REPORTED THAT NOT MUCH FORCE WAS USED. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18867945 ↗
• MalfunctionOct 11, 2023Break; Break

  ON 09/13/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06030389 THAT AN AR-8655-06 CHONDRAL PICK BROKE INSIDE THE PATIENT, CAUSING DIFFICULTIES FOR THE DOCTOR TO REMOVE THE BROKEN PART. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17912845 ↗
• MalfunctionSep 27, 2023Break; Break

  IT WAS REPORTED THAT DURING A MICROFRACTURE OF TALUS SURGERY THE DEVICE BROKE DURING USE. THE BROKEN OFF TIP OF THE DEVICE WAS THEN REMOVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-8655-06). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825380 ↗
• MalfunctionSep 8, 2023Break; Break

  ON 08/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-06 CHONDRAL PICK BROKE. THIS OCCURRED DURING A CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17712847 ↗
• MalfunctionFeb 6, 2023Break

  IT WAS REPORTED THAT DURING AN ANKLE SURGERY THE INSTRUMENT WAS INSERTED INTO THE BONE AND THE TIP BROKE OFF. FIRST THE BROKEN-OFF PIECE REMAINED IN THE BONE, BUT AT THE END OF THE SURGERY THE SURGEON COULD REMOVE THE TIP FROM THE ANKLE. 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: Foreign Body In Patient

  MAUDE report 16303155 ↗
• MalfunctionSep 6, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-06 CHONDRAL PICK TIP BROKE OFF WHILE INSIDE OF THE ANKLE JOINT DURING AN ANKLE ARTHROSCOPY PROCEDURE ON 08/05/2022. THE BROKE FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-8655-06.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362702 ↗
• MalfunctionSep 6, 2022Break; Material Twisted/Bent

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8655-06 CHONDRAL PICK BROKE, AND A AR-8655-05 CHONDRAL PICK WAS FOUND TO BE BENT. THIS OCCURRED ON (B)(6) 2022 DURING AN UNKNOWN CASE WHEN THE AR-8655-06 BROKE AND THE AR-8655-05 WAS FOUND TO BE BENT. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362688 ↗
• MalfunctionSep 6, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-06 CHONDRAL PICK BROKE DURING USE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361890 ↗
• MalfunctionAug 8, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8655-06 CHONDRAL PICK TIP BROKE OFF IN THE PATIENT. THE CENTER METAL PICK IS LOOSE AND NOT COMPLETELY SECURE TO THE HANDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15183255 ↗
• MalfunctionJun 6, 2022Break

  ON 05/19/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8655-06 CHONDRAL PICKS TIP BROKE OFF. THIS OCCURRED ON (B)(6) 2022 DURING A ROUTINE MICRO FRACTURE TECHNIQUE IN THE TALUS BONE DURING AN ANKLE SCOPE. WHEN THE SURGEON WAS HAMMERING THE MICRO FRACTURE PICKS AT A NORMAL VELOCITY, THE TIP OF THE INSTRUMENT BROKE OFF INTO THE JOINT. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14604075 ↗
• MalfunctionJan 24, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE AR 8655-06 AWL BROKE AT THE CURVED POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333338 ↗
• MalfunctionAug 31, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-8655-06, CHONDRAL PICK'S TIP SNAPPED. THIS WAS DISCOVERED DURING USE IN AN ANKLE ARTHROSCOPY ON (B)(6) 2021. THE SURGEON BROUGHT IN AN X-RAY AND WAS ABLE TO SAFELY REMOVE THE TIP FROM THE PATIENT WITHOUT ANY COMPLICATIONS. THE CASE WAS COMPETED BY USING A NEW AR-8655-06.

  Patient problems: Insufficient Information

  MAUDE report 12393614 ↗
• MalfunctionAug 24, 2021Break

  IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE, WHEN THE SURGEON PLACED THE CHONDRAL PICK INSIDE THE ANKLE JOINT, OVER THE LESION AND APPLIED PRESSURE THE TIP OF THE PICK SNAPPED OFF. THE FRAGMENT WAS RETRIEVED OUT OF THE JOINT OF THE PATIENT AND THE CASE WAS COMPLETED BY USING A NEW AR-8655-06.

  Patient problems: Insufficient Information

  MAUDE report 12362350 ↗
• MalfunctionApr 26, 2021Break

  IT WAS REPORTED THAT THE TIP OF THE AR-8655-06 PICK BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724909 ↗
• MalfunctionMar 22, 2021Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY CASE AS THE SURGEON WENT TO GO MICROFRACTURE A LESION; THE AR-8655-06 PICK TIP JUST BROKE OFF. IT THEN TOOK THE SURGEON ABOUT 30-45 MINUTES TO FISH IT OUT. THE REP REPORTED THERE WERE NO UNPLANNED INCISIONS NEEDED IN ORDER TO REMOVE THE BROKEN PIECE. THE CASE WAS COMPLETED AS PLANNED AFTER THE BROKEN TIP WAS REMOVED ARTHROSCOPICALLY.

  Patient problems: Insufficient Information

  MAUDE report 11545611 ↗
• MalfunctionMar 8, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING AN ANKEL MICROFRACTURE SURGERY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. UPDATE 18-FEB-2021: IT WAS CONFIRMED THAT THE DEVICE BROKE OFF INSIDE THE PATIENT AND THE BROKEN OFF PIECE WAS RETRIEVED FROM THE PATIENT. THE BREAKAGE DIDN¿T CAUSE ANY HARM. UPDATE 23-FEB-2021: THE WRONG LOT WAS REGISTERED IN THE COMPLAINT FORM. THE ACTUALLY AFFECTED LOT IS 1391846.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436803 ↗
• InjuryOct 23, 2020Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY AN AR-8655-06 (LOT 1391935) (FROM SET AR-8655S) WAS BEING USED. THE TIP OF THE CHONDRAL PICK BROKE OFF. ALL PIECES OF THE DEVICE WERE FULLY RETRIEVED. IN ORDER TO FINISH THE PROCEDURE THE SURGEON DISCONTINUED THE ARTHROSCOPY AND TRANSITION TO AN OPEN PROCEDURE. ADDITIONAL INFORMATION OBTAINED 10/9/20: THERE WAS NO OTHER 60 DEGREE PICK AVAILABLE TO USE. THE INITIAL MICROFRACTURE LOCATION WAS PERFORMED WITHOUT INCIDENT. THE PICK BROKE UPON SETTING BY HAND THE POSITION FOR THE SECOND LOCATION OF MICROFRACTURE. BONE QUALITY WAS REPORTED TO BE NORMAL. THE OPEN PROCEDURE WAS PART OF THE ORIGINAL SURGICAL PLAN. HOWEVER, THE ANTEROMEDIAL PORTAL DID NEED TO BE EXTENDED ABOUT ONE CM AS THE BROKEN PIECE OF THE CHONDRAL PICK WAS RETAINED WITHIN SOFT TISSUE UPON THE SURGEON'S INITIAL ATTEMPT TO REMOVE IT ARTHROSCOPICALLY.

  Patient problems: Insufficient Information

  MAUDE report 10730445 ↗
• InjuryOct 6, 2020Break; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE AR-8655-06 CHONDRAL PICK WAS INSERTED INTO THE ANKLE JOINT FOR AN OCD LESION CASE. PER THE REP PRESENT, THE SURGEON HAD APPLIED SLIGHT PRESSURE TO THE PICK PRIOR TO MALLETING AND THE TIP BROKE OFF INTO THE JOINT. THE SURGEON TRIED TO RETRIEVE IT WITH A GRASPER, BUT IT MIGRATED TO THE BACK OF THE ANKLE. THEY TOOK AN X-RAY TO LOCATE IT AND THEN 4 ADDITIONAL INCISIONS WERE NEEDED TO RETRIEVE THE TIP FROM THE POSTERIOR OF THE TIBULA. THE CASE WAS THEN COMPLETED. PATIENT IS FEMALE, (B)(6) YEARS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10634206 ↗
• InjurySep 10, 2020Break

  IT WAS REPORTED DURING AN ANKLE ARTHROSCOPY THE TIP OF THE CHONDRAL PICK BROKE OFF INSIDE THE PATIENT. ALL WAS RETRIEVED. TO PROCEED THE SURGEON USED K-WIRES AND THE CASE COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10513504 ↗