Arthrex® AR-1981-10SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867025356), received between Nov 8, 2016 and Jul 30, 2025 — classified as 4 injuries, 12 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.

• MalfunctionJul 30, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN OATS OSTEOCHONDRAL LESION PROCEDURE THE INNER PART OF THE RECIPIENT HARVESTER DID NOT FIT IN THE DELIVERY TUBE, IT WAS STANDING PROUD FROM THE START. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BY IMPROVISING WITH A DONOR HARVESTER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665593 ↗
• MalfunctionFeb 7, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE METAL PLATE ON THE PUNCH BROKE OFF. 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 21331830 ↗
• MalfunctionJun 10, 2024Break; Break

  ON 4/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THE DONOR T-HANDLE FROM AN AR-1981-06S SINGLE USE OSTEOCHONDRAL AUTOGRAFT TRANSFER SYSTEM OATS SET AUTOGRAFT DIAMETER 6 MM METAL BEGAN TO WARP AFTER IT WAS INSERTED, AND AT THE DESIRED DEPTH. THE SURGEON WAS ABLE TO REMOVE THE DONOR T-HANDLE WITHOUT BREAKING IT. AN AR-8981-06S SMALL JOINT OATS, DONOR T-HANDLE WAS OPENED AND USED. THE SAME THING HAPPENED; IT WARPED, BUT DURING REMOVAL, IT BROKE IN THE CONDYLE. THEN, THE SURGEON ATTEMPTED TO USE AN AR-1981-08S, OATS SIZE 8MM, AND AN AR-1981-10S OATS, SIZE 10 MM, BUT IT WOULD NOT HARVEST A PLUG. AFTER AN EXTENDED PERIOD OF TIME, THE SURGEON WAS ABLE TO REMOVE THE BROKEN METAL WITH A CLAMP. THE SURGEON WAS ABLE TO USE THE PLUG OUT OF THE BROKEN PIECE AND COMPLETED THE CASE SUCCESSFULLY. THIS WAS DISCOVERED DURING AN AUTOGRAFT OATS TRANSFER PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 4/18/2023: THE CASE WAS DELAYED ABOUT FORTY-FIVE MINUTES TO AN HOUR, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 19498909 ↗
• MalfunctionJun 5, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A CARTILAGE REPAIR SURGERY THE DOWNLOAD TOOL WAS CURVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19470189 ↗
• MalfunctionMay 16, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 10/07/2021 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1981-10S TRANSFER SYSTEM OATS DEVICE BENT DURING AN ANKLE SURGERY. THE SURGEON COMPLETED THE PROCEDURE USING A NEW DEVICE WITH THE SAME PART NUMBER. THERE WAS NO PATIENT EFFECT REPORTED. ADDITIONAL INFORMATION PROVIDED ON 12/30/2021 : THE CALCANEUS RECEPTOR SAMPLE WAS TO BE TAKEN FROM THE PATIENT. SCLEROTIC BONE IS PERFORMED AT THE TIME OF INSERTING THE DEVICE TO PREPARE THE RECEIVING AREA, THE EDGES ARE BENT AND NICKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331484 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN OATS SURGERY THE PLUNGER BROKE OFF IN THE KNEE. THE BROKEN PIECE WAS RETRIEVED OUT OF PATIENT. 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. UPDATE SWIT (B)(6) 2023: THE AFFECTED DEVICE OF THE SET HAS THE NUMBER C2782-01.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843597 ↗
• InjuryApr 11, 2023Defective Device; Defective Device

  IT WAS REPORTED ON (B)(6) 2023 BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1981-10S DONOR GRAFT COULD NOT BE REMOVED FROM THE DONOR HARVESTER. THE SURGERY WAS NOT COMPLETED AND THE WOUND CLOSED. CASE INVOLVEMENT, ABORTED PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16715692 ↗
• MalfunctionFeb 13, 2023Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN OATS SURGERY WHILE THE SURGEON INSERTED THE DEVICE THE CUTTING EDGE BECAME BENT AND BROKE. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361759 ↗
• InjuryDec 27, 2022Break; Difficult to Remove; Device Fell

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT PATIENT UNDERWENT AN ALLOGRAFT OATS TRANSFER TO THE PATELLA PROCEDURE ON (B)(6) 2022. AN AR-1981-10S OSTEOCHONDRAL AUTOGRAFT TRANSFER SYSTEM OATS WAS USED TO COMPLETE THE PROCEDURE. DURING THE PROCEDURE, A HARVESTER WAS USED TO EXTRACT A PLUG FROM THE PATELLA. THE PATIENT'S BONE WAS TOO HARD, AND THE PLUG DID NOT COME OUT WITH THE HARVESTER. A REAMER WAS THEN USED TO REAM OUT THE RECIPIENT SITE. IT WAS THIS TIME THAT THE HARVESTER BROKE OFF AND FELL INTO THE WOUND DURING THE ATTEMPTED PLUG EXTRACTION. HOWEVER, THIS REMAINED UNKNOWN UNTIL THE PATIENT WENT FOR A TWO WEEK FOLLOW UP VISIT AND AN X-RAY SHOWED A METAL IN THE PATIENT'S JOINT. ON (B)(6) 2022, PATIENT HAD A REVISION PROCEDURE AND HAD THE BROKEN TIP REMOVED.

  Patient problems: Foreign Body In Patient; Laceration(s)

  MAUDE report 16051630 ↗
• MalfunctionJun 13, 2022Break

  IT WAS REPORTED THAT DURING AN EXTRACTION OF CANCELLOUS BONE AT THE ILIAC CREST AT THE THIRD ATTEMPT, THE SMALL PLATE INSIDE THE PUNCH BROKE OFF. THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE OUT OF THE PATIENT AND DECIDED THAT NO FURTHER CANCELLOUS BONE NEEDED TO BE RETRIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676620 ↗
• MalfunctionNov 2, 2021Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A KNEE SURGERY WITH AN OSTEOCHONDRAL AUTOGRAFT TRANSFER SYSTEM THE TIP OF THE RECIPIENT SET HAS LOOSENED, PREVENTING THE PREPARATION OF THE HEALTHY CORE RECIPIENT SITE. THE BROKEN FRAGMENTS WERE 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-1981-08S + AR-1981-06S). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12737877 ↗
• MalfunctionAug 25, 2021Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A KNEE-CARTILAGE TRANSPLANTATION ON (B)(6) 2021, THE ORANGE RUBBER PART NEAR THE TIP OF GRAFT DRIVER BROKE INTO PIECES DURING DIRECT PATIENT INTERACTION. ONE PART OF THE FRAGMENT WAS UNACCOUNTED FOR AND MAY HAVE REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING THE COMPLAINT DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12364413 ↗
• MalfunctionJul 20, 2021Break

  IT WAS REPORTED THAT DURING A CANCELLOUS BONE PLASTIC SURGERY THE DONOR OF THE DEVICE SET BROKE OFF AND FELL INTO THE PATIENT. THE DEVICE BROKE ALTHOUGH NO FORCE WAS USED WITH THE DEVICE. THE BROKEN OFF PIECE WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 12198160 ↗
• MalfunctionJun 16, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON MALLETED THE RECIPIENT OATS INTO THE FEMORAL CONDYLE. HE WAS HAVING A HARD TIME GOING IN SO HE MALLETED A LITTLE HARDER. ONCE HE GOT TO THE APPROPRIATE LEVEL, HE FOLLOWED THE TECHNIQUE TO PULL THE PLUG OUT AND HALF OF THE BONE PLUG CAME OUT. WHEN HE LOOKED AT THE TIP OF THE RECIPIENT HARVESTER, HE NOTICED HALF OF THE TIP WAS BEVELED. THIS CAUSED THE HOLE TO BE LARGER THAN THE DONOR GRAFT. TO COMPLETE THE PROCEDURE THE SURGEON HAD TO IMPROVISE. SURGEON PLACED THE PLUG IN AND FILLED BONE MATRIX AROUND THE EDGE AND COVERED WITH THE SEAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10159927 ↗
• InjuryFeb 10, 2017Separation Failure

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO DISENGAGE THE GRAFT FROM THE BONE. THE SURGEON CHANGED THE TECHNIQUE AND FRAGMENT FIXATION WAS DONE WITH A SCREW AND SURGERY WAS FINISHED WELL. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Information

  MAUDE report 6322689 ↗
• InjuryNov 8, 2016Failure to Cut

  IT WAS INITIALLY REPORTED THAT THE HARVESTER FAILED TO CUT AND PULL OUT THE DONOR BONE DURING OATS/ANKLE CASE. ADDITIONAL INFORMATION RECEIVED 10/20/2016: TWO INSTRUMENTS (RECIPIENT AND DONOR HARVESTER) COMPOSED OF 10MM SINGLE USE OATS FAILED SO IT COULDN'T REMOVE (TEAR OFF) BONE BLOCK. THE PROCEDURE WAS SWITCHED WITH CUTTING TOOLS LIKE BURR AND SHAVER HAND-PIECE WERE USED DURING THE OPERATION TO FINISH THE SURGERY. THE INSTRUMENT BEING RETURNED FROM OATS SET AR-1981-10S IS AR-1981SA-10D LOT 67251515.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6085160 ↗