Arthrex® AR-8550BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867043930), received between Aug 9, 2016 and Sep 22, 2026 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Material Fragmentation

  It was reported that during the acromioclavicular joint resection, small metal particles were released from the AR-8550BC. The surgeon did not apply excessive leverage, as the patient¿s bone was not particularly hard. The metal fragments were retrieved from the patient. Per complaint reporter there was no harm for patient, operator or third party. The surgery was finished successfully with the same device. It was not necessary to switch the surgical technique or do a second surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855108 ↗
• MalfunctionSep 22, 2026Material Fragmentation

  It was reported that during the acromioclavicular joint resection, small metal particles were released from the AR-8550BC. The surgeon did not apply excessive leverage, as the patient¿s bone was not particularly hard. The metal fragments were retrieved from the patient. Per complaint reporter there was no harm for patient, operator or third party. The surgery was finished successfully with the same device. It was not necessary to switch the surgical technique or do a second surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854934 ↗
• MalfunctionMar 5, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING THE KNEE ARTHROSCOPY, THE DEVICE CAUSED METAL ABRASION AND TURNED BLACK AT THE TIP. THE METAL ABRASION WAS RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518974 ↗
• MalfunctionFeb 20, 2026Material Fragmentation

  ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8550BC BONECUTTER WAS PRODUCING METAL FRAGMENTS. THIS WAS DISCOVERED DURING A DISTAL CLAVICLE EXCISION PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24400576 ↗
• MalfunctionFeb 20, 2026Material Fragmentation

  ON 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8550BC BONECUTTER WAS PRODUCING METAL FRAGMENTS. THIS WAS DISCOVERED DURING A DISTAL CLAVICLE EXCISION PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24400483 ↗
• MalfunctionDec 18, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING THE SHOULDER ROTATOR CUFF SURGERY, THE DEVICE PRODUCED METAL SHAVINGS IN 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. ON (B)(6) 2025 (B)(6) - FURTHER INFORMATION RECEIVED FROM ARTHREX AT: THE METAL SHAVINGS WERE REMOVED AS THOROUGHLY AS POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837442 ↗
• MalfunctionAug 4, 2025Material Fragmentation; Material Fragmentation

  UPDATE 17-JUL-2025: THE METAL DEBRIS REMAINED INSIDE THE PATIENT BECAUSE IT WAS NOT POSSIBLE TO REMOVE THE FRAGMENTS.

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

  MAUDE report 22707200 ↗
• MalfunctionOct 3, 2024Material Fragmentation; Material Fragmentation

  ***UPDATE AVOE (B)(6) 2024 IT WAS CONFIRMED THAT THE FRAGMENTS REMAINED INSIDE THE PATIENT AS THESE WERE TOO SMALL TO RETRIEVE.

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

  MAUDE report 20359152 ↗
• MalfunctionOct 3, 2024Material Fragmentation; Material Fragmentation

  UPDATE AVOE 02-OCT-2024: IT WAS CONFIRMED THAT THE FRAGMENTS REMAINED INSIDE THE PATIENT AS THESE WERE TOO SMALL TO RETRIEVE.

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

  MAUDE report 20359055 ↗
• MalfunctionSep 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY AFTER THE DEVICE WAS CLOGGED, THE BLADE WAS TAKEN APART AS USUAL AND BRIEFLY CLEANED. WHEN THE INNER PART OF THE BLADE WAS RETURNED, THE ¿FOIL¿ JAMMED DIRECTLY AND WAS PULLED UP SO MUCH THAT THE BLADE WAS NOT USABLE ANYMORE. 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 20269050 ↗
• MalfunctionJun 19, 2024Break; Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8550BC BONE CUTTER BENT. THIS OCCURRED DURING A PROCEDURE WHILE IN THE SUBACOMIAL SPACE, HE WAS RUNNING THE DEVICE IN FORWARD AT 8000 RPMS WHEN IT BENT, THE DEVICE BROKE AFTER BEING REMOVED FROM THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567612 ↗
• MalfunctionJan 19, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE SHAVER DEVICE BONE CUTTER AR-8550 (LOT: 15031463) WAS DROPPING ¿SCOBS¿. 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. UPDATE AVOE (B)(6) 2024 IT WAS CONFIRMED THAT METALL SHAVINGS WERE PRODUCED WITH THE DEVICE AND NOT ALL FRAGMENTS COULD BE REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18544607 ↗
• MalfunctionOct 12, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-8550BC, BONE CUTTER,5.5MM X 13CM IS SHEDDING IRON FILINGS INTO THE JOINT WHEN DOING A ACROMIOPLASTY PROCEDURE ONLY WHEN DOING THE AC JOINT RESECTION OF THE PROCEDURE ON (B)(6) 2023. THIS HAPPENED WITH SAME PRODUCT UNDER 2 DIFFERENT LOT NUMBERS LOT 14557184 AND 14918873. CUSTOMER DOES NOT LIKE METAL FILINGS IN THE JOINT AND WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY BY USING THE SHAVER TO SUCK OUT THE DEBRIS. THE PROCEDURE TOOK MORE TIME THAN NORMAL TO COMPLETE. THE CUSTOMER WOULD LIKE TO BE INFORMED ABOUT WHY THIS OCCURS AND IF THERE WERE POSSIBLE WAYS THAT ARTHREX COULD RECTIFY IT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918581 ↗
• MalfunctionOct 11, 2023Material Fragmentation; Material Fragmentation

  ON 14TH SEPTEMBER 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-8550BC, BONE CUTTER,5.5MM X 13CM IS SHEDDING IRON FILINGS INTO THE JOINT WHEN DOING A ACROMIOPLASTY PROCEDURE ONLY WHEN DOING THE AC JOINT RESECTION OF THE PROCEDURE ON (B)(6) 2023. THIS HAPPENED WITH SAME PRODUCT UNDER 2 DIFFERENT LOT NUMBERS LOT 14557184 AND 14918873. CUSTOMER DOES NOT LIKE METAL FILINGS IN THE JOINT AND WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY BY USING THE SHAVER TO SUCK OUT THE DEBRIS. THE PROCEDURE TOOK MORE TIME THAN NORMAL TO COMPLETE. THE CUSTOMER WOULD LIKE TO BE INFORMED ABOUT WHY THIS OCCURS AND IF THERE WERE POSSIBLE WAYS THAT ARTHREX COULD RECTIFY IT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914604 ↗
• MalfunctionApr 14, 2023Break; Break

  IT WAS REPORTED THAT DURING A RM SURGERY METAL DEBRIS WAS CAUSED BY THE DEVICE. THE DEBRIS WAS REMOVED 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 16743510 ↗
• MalfunctionDec 5, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8550BC BONE SAW PROXIMAL END BROKE OFF SHAVER "SOUNDED LIKE IT MELTED OFF". CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 15914340 ↗
• MalfunctionMay 16, 2022Material Fragmentation

  ON 4/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-8550BC BONE CUTTER IS CREATING DEBRIS DURING USE. ALL DEBRIS HAS BEEN REMOVED FROM THE CLAVICLE USING A SHAVER TO REMOVE THE METAL SHAVING ALONG WITH THE USE OF A BURR TO FINISH THE DISTAL CLAVICLE EXCISION. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14407261 ↗
• MalfunctionSep 21, 2021Material Fragmentation

  ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8850BC BONE CUTTER PRODUCED DEBRIS IN A PATIENT'S JOINT WHILE FORWARD BURRING. THIS WAS DISCOVERED DURING USE IN AN UNSPECIFIED PROCEDURE PERFORMED ON 09/03/2021. THE CASE WAS COMPLETED USING A NEW BURR. ADDITIONAL INFORMATION: REP RETURNED CONTACT ON 9/14, CONFIRMED THE BATCH AS 13248045, CONFIRMED ALL FRAGMENTS WERE REMOVED FROM PATIENT. CONFIRMED NO DUALWAVE TUBING AND NO UNINTERRUPTED IRRIGATION FLOW.

  Patient problems: Insufficient Information

  MAUDE report 12507982 ↗
• InjuryDec 20, 2019Flaked; Defective Device

  IT WAS REPORTED VIA FDA MEDWATCH REPORT (3600840000-2019-8018) THAT DURING A COMPLETE ROTATOR CUFF REPAIR OF THE LEFT SHOULDER IN (B)(6) 2019, THE DR. WAS PERFORMING A LEFT SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR. DR. NOTICED THAT WHILE USING THE ARTHREX 5.5 BONE CUTTER SHAVER THAT "METAL FLAKES" CAME OFF IN THE WOUND. THE SURGICAL TECHNOLOGIST STATED THAT THE SHAVER WAS RUBBING OR STICKING WHEN SHE TRIED TO MANUALLY ROTATE THE BLADE WHILE IT WAS OFF THE ARTHREX SHAVER HANDLE. DR. SAID THAT HE IRRIGATED THE WOUND. THE LOT NUMBER OF THE EFFECTED SHAVER HAS BEEN REMOVED FROM THE STOCK AND A DEFECTIVE PRODUCT REPORT HAS BEEN FILED. THE FDA MEDWATCH REPORT RECEIVED DID NOT CONTAIN THE SPECIFIC DATE OF THE (B)(6) 2019 PROCEDURE. (B)(6) 2019 HAS BEEN ENTERED AS THE DATE OF PROCEDURE UNTIL A SPECIFIC DATE CAN BE OBTAINED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9506035 ↗
• InjuryDec 10, 2019Break

  IT WAS REPORTED THAT THE ARTHREX BONE CUTTER AR-8550BC WAS USED DURING AN ACROMIOPLASTY SURGERY. DURING THE MILLING MODE THE CHIP OF THE DEVICE BROKE OFF. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN FRAGMENT. IT WILL REMAIN INSIDE THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE COMPLAINT DEVICE. NO FURTHER INFORMATION RECEIVED AT THE MOMENT. ARTHREX GMBH WILL ASK THE CUSTOMER WHAT IS MEANT BY THE CHIP OF THE DEVICE. ADDITIONAL INFORMATION OBTAINED 03-DEC-2019: ACCORDING TO THE CUSTOMER THERE WERE METAL SHAVINGS SEEN AND THE WILL REMAIN INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9443814 ↗
• InjuryJul 31, 2019Material Fragmentation

  IT WAS REPORTED THAT THE BONECUTTER, AR-8550BC, WAS BEING USED DURING ACLR PREPARATION WHEN METAL SHARDS APPEARED. ADDITIONAL INFORMATION PROVIDED ON 7/26/19: NOTCHPLASTY WAS THE SURGICAL TECHNIQUE BEING PERFORMED WHEN THE ISSUE OCCURRED. THE MAJORITY OF THE METAL FRAGMENTS WERE REMOVED VIA SUCTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8845631 ↗
• InjuryOct 27, 2016Metal Shedding Debris

  IT WAS REPORTED THAT SHAVER BLADE PRODUCED DEBRIS DURING SURGERY. METAL SHAVINGS REMAINED IN PATIENT AND COULD NOT BE RETRIEVED. SURGERY WAS FINISHED SUCCESSFULLY USING ANOTHER SHAVER BLADE OF THE SAME TYPE MODEL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6060444 ↗
• InjuryAug 9, 2016Metal Shedding Debris

  IT WAS REPORTED THAT THE SHAVER CAUSED METAL DEBRIS. THIS WAS ALSO VISIBLE UNDER POST-SURGICAL MRI. SHAVINGS REMAINED IN THE PATIENT. SURGERY PERFORMED WAS A SUB-ACRMOALIA DECOMPRESSION. SURGERY WAS SUCCESSFULLY FINISHED,USING ANOTHER IDENTICAL SHAVER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5856341 ↗