Arthrex® AR-8500TDRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867043923), received between Jul 20, 2021 and Mar 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break

  ON 19-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8500TD TORPEDO SHAVER TIP BROKE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628324 ↗
• MalfunctionMar 18, 2026Break

  ON 19-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8500TD TORPEDO SHAVER TIP BROKE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628249 ↗
• MalfunctionMay 18, 2023Material Fragmentation; Material Fragmentation

  ON 05/02/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500TD TORPEDO SHAVER BLADE SNAPPED OFF INTO TWO PIECES. THIS OCCURRED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2023 THE BLADE BROKE INTO 2 PIECES INSIDE THE PATIENT AND DEBRIS WAS PRODUCED. THE PIECES WERE REMOVED BY HAND. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16955829 ↗
• MalfunctionDec 12, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-8500TD, TORPEDO, 5.0MM X 13 CM BROKE WHILST USING IN THE PATIENT. IT WAS A 5MM ONE AND APPARENTLY IT BROKE AT THE INTERNAL SHAFT. THIS WAS DISCOVERED DURING USE AND A CASE WAS INVOLVED. TO COMPLETE THE PROCEDURE, AN ALTERNATE SHAVER WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 15958893 ↗
• MalfunctionAug 31, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY A METAL PART OF THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN OFF PART 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 DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 12393132 ↗
• MalfunctionAug 17, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A¿SALES REPRESENTATIVE¿VIA¿SEMS¿THAT 2 OF THE AR-8500TD¿TORPEDO, 5.0MM X 13 CM METAL TIPS BROKE OFF DURING THE PROCEDURE. THIS WAS¿DISCOVERED DURING¿A SHOULDER PROCEDURE.¿HOW THE PROCEDURE WAS COMPLETED IF OCCURRED DURING USE.¿A 3RD AR-8500TD SHAVER WAS OPENED TO COMPARE, MAKING SURE ALL PIECES WERE FOUND. A PORTABLE X-RAY WAS DONE WHILE THE PATIENT WAS STILL IN THE OR, NO FOREIGN OBJECTS WERE SEEN ON X-RAY. ADDITIONAL INFORMATION 8/3/2021 THE SALES REP REPORTED THE INCIDENT OCCURRED DURING ONE OF THE DR'S. SHOULDER SCOPES. TWO TORPEDO SHAVERS WERE BROKEN DURING A NORMAL BURSECTOMY IN THE SUB-ACROMIAL SPACE.

  Patient problems: Insufficient Information

  MAUDE report 12333389 ↗
• MalfunctionJul 20, 2021Break; Failure to Cut

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE INNER AND OUTER BLADE SHEATH WAS NOT PROPERLY CUTTING AND CAUSED A SMALL METALLIC PIECE TO BE SHAVED OFF. THE CASE WAS COMPETED BY USING A NEW AR-8500TD. ADDITIONAL INFORMATION PROVIDED 6/30/21: THE SHAVER ATTACHMENTS WERE OPENED AND ALL OF THEM HAD THE SAME ISSUE. THE ENTIRE BOX WAS COMPROMISED AND COULD NOT BE USED. THE SURGEON ONLY USED 1 DURING THE CASE AND OPENED THE REST OF THE BOX TO CHECK THE DEVICES AND DETERMINED THIS ISSUE. THE CASE WAS COMPLETED BY USING A NEW AR-8500TD FROM A DIFFERENT LOT.

  Patient problems: Insufficient Information

  MAUDE report 12198192 ↗