NA 214620Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705004034), received between Jan 22, 2019 and Mar 19, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE ARTHRO RASP 20 DOWNBEND DEVICE SHAFT PART OF THE RASP BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644461 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT THE ARTHRO RASP 20 DOWNBEND *EA DEVICE WAS BROKEN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053463 ↗
• MalfunctionJun 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ARTHRO RASP 20 DOWN BEND WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476904 ↗
• MalfunctionMay 17, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING JOINT LIP REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE ARTHRO RASP 20 DOWNBEND *EA DEVICE BROKE OFF FROM THE CURVED TIP. THE BROKEN PIECES WERE REMOVED FROM THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343641 ↗
• MalfunctionFeb 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE ARTHRO RASP 20 DOWNBEND DEVICE WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672671 ↗
• MalfunctionDec 27, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED FROM JAPAN BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE CUTTING DEVICE WAS USED TO REMOVE AN ARTICULAR LIP FROM A GLENOID, AND THE RASP TIP WAS DEFORMED AND COULD NOT BE USED FOR SURGERY. ANOTHER RASP WAS USED IN THE SAME WAY, AND IT WAS ALSO DEFORMED. WHEN THE SURGEON ATTEMPTED TO PUT IT BACK ON THE OPERATING TABLE, THE RASP IN QUESTION BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF THE 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402084 ↗
• MalfunctionApr 5, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RASP - 20 DEGREES DOWN BEND DEVICE WAS BENT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685685 ↗
• MalfunctionSep 9, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT THE RASP 20° DOWN BEND DEVICE WAS BROKEN AT THE EDGE OF THE HANDLE AND THE RASP (SHAFT). THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391624 ↗
• MalfunctionMay 4, 2022Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 IN (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RASP 20° UP BEND WAS BENT. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279006 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SHAFT ON THE ARTHRO RASP 20 DOWNBEND DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254231 ↗
• MalfunctionApr 28, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE THAT THE ARTHRO RASP 20 DOWNBEND EA IS PHYSICALLY BROKEN. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE LOT NUMBER OF THE DEVICE IS UNKNOWN AND COULD NOT BE VERIFIED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10007329 ↗
• MalfunctionSep 24, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE ARTHRO RASP 20 DOWNBEND *EA DEVICE WAS BROKEN ON THE BORDER BETWEEN THE GRIP AND SHAFT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9110295 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER ARTHROSCOPY STABILIZATION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ARTHRO RASP 20 DOWNBEND EA DEVICE BROKE BETWEEN THE METAL SHAFT AND THE HANDLE. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHILE THE SURGEON WAS RASPING THE GLENOID. IT WAS NOT REPORTED IF THERE WAS DELAY IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266560 ↗