Arthrex® AR-8550OBTRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867044050), received between Nov 28, 2018 and Oct 17, 2025 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A SURGERY THAT THE SHAVER BLADE BROKE WHEN THE SURGEON ATTEMPTED TO REMOVE IT. THE BROKEN PIECES 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 23322194 ↗
• MalfunctionDec 27, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SURGERY WHEN IN USE, THE DEVICE WAS NOISY, DEFLECTS AND WAS OUT OF ALIGNMENT. 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 21026862 ↗
• MalfunctionJun 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ASD-PROCEDURE SMALL PIECES OF PLASTIC FELL OFF INSIDE THE PATIENT. SAME THING HAPPENED TWICE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. THE FRAGMENTS REMAINED INSIDE THE PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 17-MAY-2024: FURTHER INFORMATION WAS PROVIDED THAT THE FAILURE OCCURRED WITH TWO DEVICES DURING THE SAME SURGERY. PLASTIC PIECES WERE INSIDE THE PATIENT BUT THEY WERE REMOVED WITH THE SHAVER. ACCORDING TO CUSTOMER BOTH BURRS HAD LOOSE PLASTIC PIECES COMING OUT FROM THE TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 19508442 ↗
• MalfunctionJun 11, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ASD-PROCEDURE SMALL PIECES OF PLASTIC FELL OFF INSIDE THE PATIENT. SAME THING HAPPENED TWICE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. THE FRAGMENTS REMAINED INSIDE THE PATIENT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE (B)(6) 2024 FURTHER INFORMATION WAS PROVIDED THAT THE FAILURE OCCURRED WITH TWO DEVICES DURING THE SAME SURGERY. PLASTIC PIECES WERE INSIDE THE PATIENT BUT THEY WERE REMOVED WITH THE SHAVER. ACCORDING TO CUSTOMER BOTH BURRS HAD LOOSE PLASTIC PIECES COMING OUT FROM THE TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 19508430 ↗
• MalfunctionJun 3, 2024Separation Failure; Separation Failure

  ON 09/24/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8550OBT OVAL BURR, WILL NOT DETACH FROM THE SHAVER HAND PIECE. TS: PHYSICAL.

  Patient problems: Insufficient Information

  MAUDE report 19451720 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8550OBT BURR PLASTIC TAB ON BURR HUB BROKE DURING USE. CASE INVOLVEMENT, DEVICE BREAKS DURING USE.

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

  MAUDE report 16565110 ↗
• MalfunctionJul 18, 2022Break

  ON 6/28/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THREE AR-8550OBT OVAL BURRS BROKE DURING THE CASE. THE PIECES WERE ALL RETRIEVED AND THE CASE WAS COMPLETED WITH NO PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040577 ↗
• MalfunctionMay 16, 2022Activation, Positioning or Separation Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8550OBT BURR DID NOT MAKE IT INTO THE JOINT. THIS OCCURRED DURING AN UNKNOWN PROCEDURE WHEN THE BURR SPUN THROWING METAL PIECES INTO THE JOINT. THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407166 ↗
• InjuryFeb 14, 2019Overheating of Device; Excessive Heating; Excessive Heating

  UPDATE SWIT 26-FEB-2019: AN ACROMIOPLASTY SURGERY WAS PERFORMED. THE BURN WAS TREATED WITH A BANDAGE. PATIENT DID NOT REQUIRE AN OVERNIGHT STAY DUE TO THE BURN. THE SAME DEVICE WAS USED ANYWAY TO COMPLETE THE PROCEDURE. UPDATE SWIT 27-FEB-2019: IT WAS REPORTED THAT THE BURN INVOLVED A LATE HEALING. SO THE SURGEON DECIDED DO A SECOND SURGERY - WITH TRIMMING AND RECOVERY OF THE SCAR. THE LESION WILL HEAL BUT WITH AESTHETIC DAMAGE. IT WAS NOT A REVISION SURGERY CAUSE NO ARTHREX DEVICE WAS REPLACED OR REMOVED.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 8340327 ↗
• InjuryDec 20, 2018Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING A CUFF REPAIR SURGERY THE OVERHEATING OF THE CUTTER CAUSED A PATIENT BURN. 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: Burn(s); Burn, Thermal

  MAUDE report 8185053 ↗
• InjuryDec 18, 2018Excessive Heating; Overheating of Device; Noise, Audible; Excessive Heating

  ADDITIONAL INFORMATION PROVIDED 12/27/2018: THE PUMP USED WAS AN ARTHREX DUALWAVE PUMP USING INFLOW/OUTFLOW. INFLOW PRESSURE WAS 60, OUTFLOW CANNULA SUCTION WAS MEDIUM, SHAVER SUCTION WAS HIGH. THE SURGEON USES THE PUMP OUTFLOW WITH THE CANNULA TUBING CONNECTED TO AN OUTFLOW CANNULA, AND THE SHAVER TUBING ATTACHED TO THE SHAVER. HE USES SUCTION FROM OUR OUTFLOW PUMP, WHICH IS HOOKED UP TO A SEPARATE MANIFOLD ON THE NEPTUNE, SET ON LOW SUCTION. THIS OCCURRED DURING A ROTATOR CUFF PROCEDURE. SURGEON LITERALLY PUT IT IN THE SHOULDER FOR 10 SECONDS, IT STARTED MAKING A WEIRD SOUND, THEN STOPPED COMPLETELY. REP GRABBED ANOTHER BURR, AND AS HE WAS DOING THAT, HE NOTICED A BURN MARK ON THE SHOULDER WHERE THE BURR WAS. THEN AS THE TECH WAS REMOVING THE BURR FROM THE HANDPIECE, SHE SAID, "WOW, THIS IS SO HOT!". THE REP PUT IN THE NEW BURR AND EVERYTHING WORKED PERFECT FOR THE REST OF THE CASE.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 8174729 ↗
• InjuryNov 29, 2018Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THEY WERE USING THE BURR TO RESECTION 5MM OF DISTAL CLAVICLE. THEY WERE HEARING A HIGH PITCHED NOISE, WHICH THEY THOUGHT WAS FROM THE SHAVER SO THEY REPLACED THE SHAVER. THEY RECONNECTED THE BURR TO ANOTHER SHAVER. THE NOISE CONTINUED AND THE SHAFT OF THE BURR GOT TOO HOT TO TOUCH AND THE PATIENT GOT BURNED AT THE POSTERIOR PORTAL. THEY USED SILVER COMPOUND ON THE WOUND. THERE WERE NO ADDITIONAL INCISIONS OR HOSPITALIZATION REQUIRED AND THE CASE WAS COMPLETED.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 8114738 ↗
• InjuryNov 28, 2018Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT THE OVAL BURR, AR-8550OBT, WAS BEING USED IN A CASE AND SHORTLY AFTER IT BEGAN SPINNING, THE BURR BECAME HOT AND BURNED THE PATIENT'S SKIN. ADDITIONAL INFORMATION PROVIDED (B)(6) 2018: THIS EVENT OCCURRED WHILE THE SURGEON WAS PERFORMING A SUBACROMIAL DECOMPRESSION DURING A SHOULDER ARTHROSCOPY PROCEDURE. THE PATIENT WAS BURNED ON THEIR SHOULDER; HOWEVER, NO PHOTOS WERE CAPTURED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2018: A PHOTO WAS TAKEN AT THE PATIENT'S FOLLOW-UP APPOINTMENT.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 8110257 ↗
• InjuryNov 28, 2018Excessive Heating; Overheating of Device; Excessive Heating

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THEY WERE USING THE BURR TO RESECTION 5MM OF DISTAL CLAVICLE; THEY WERE HEARING A HIGH PITCHED NOISE SO THEY CHANGED THE BURR OUT TO COMPLETE THE CASE. THE BURR HAD BECOME HEATED AND THERE WAS A BURN TO THE PATIENT AT THE POSTERIOR PORTAL. THEY USED SILVER COMPOUND ON THE WOUND. THERE WERE NO ADDITIONAL INCISIONS OR HOSPITALIZATION REQUIRED AND THE CASE WAS COMPLETED.

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 8109840 ↗