Formula 0380544100Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327054996), received between Oct 18, 2018 and May 6, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Material Fragmentation

  IT WAS REPORTED THAT UPON ATTEMPTING TO UTILIZE THE INSTRUMENT, AND PRIOR TO INSTRUMENT ENTERING PATIENT, THE SURGEON NOTED THAT THE INSTRUMENT WAS NOT BEHAVING AS NORMAL, AND HANDED INSTRUMENT BACK TO SURGICAL TECH, WHOM DISCOVERED THAT A PORTION OF THE INTERNAL CUTTING MECHANISM HAD BROKEN OFF INSIDE THE OUTER PORTION OF THE INSTRUMENT (THE CUTTING PORTION OF THE BURR HAD BROKEN OFF INSIDE THE TROCAR). ALL PARTS REMAINED INSIDE THE INSTRUMENT, AND ALL PARTS ARE ACCOUNTED FOR. NO PORTION OF THE INSTRUMENT WENT INSIDE THE PATIENT DURING SURGERY.

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

  MAUDE report 25105291 ↗
• MalfunctionDec 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRODUCT BROKE OFF INTO A PATIENT DURING THE PROCEDURE. ALL OF THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23855852 ↗
• MalfunctionSep 19, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE SHAVER BROKE OFF. THEY WERE ABLE TO REMOVE ALL THE PARTS FROM THE JOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23099748 ↗
• MalfunctionApr 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INNER CYLINDER OF THE SHAVER WAS BROKEN. DURING THE ELBOW ARTHROSCOPY, IT WAS APPARENTLY BROKEN WHILE SHAVING THE AREA BEHIND THE PORTAL INSERTION SITE. THE DOCTOR SAID THAT HE MAY HAVE USED TOO MUCH FORCE, BUT HE HAD USED IT MANY TIMES BEFORE AND HAD NEVER HAD ANYTHING LIKE THIS HAPPEN, SO HE ASKED HIM TO HAVE IT CHECKED. CUSTOMER REPLACED THE DEVICE TO COMPLETE THE SURGERY. PER IMAGES RECEIVED, THE TIP BROKE OFF CLOSE TO THE DISTAL END BUT APPEARS TO HAVE STAYED INSIDE THE OUTER BLADE.

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

  MAUDE report 21886775 ↗
• MalfunctionFeb 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BREAKING DURING THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308368 ↗
• MalfunctionOct 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20412398 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302753 ↗
• MalfunctionMay 25, 2023Break; Break

  IT WAS REPORTED THAT THE DISTAL TIP OF THE PRODUCT BROKE OFF IN THE KNEE JOINT. THE PATIENT CONTINUED TO EXPERIENCE PAIN IN THE JOINT SPACE. AN ADDITIONAL SURGERY WAS REQUIRED TO RETRIEVE THE BROKEN TIP FROM THE JOINT SPACE.

  Patient problems: Pain

  MAUDE report 17005522 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DEVICE FELL OFF DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345238 ↗
• MalfunctionJun 25, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

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

  MAUDE report 12068909 ↗
• MalfunctionMay 21, 2020Break; Break

  IT WAS REPORTED THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10080622 ↗
• MalfunctionFeb 11, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694277 ↗
• MalfunctionFeb 10, 2020Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DEVICE CAME OFF DURING THE PROCEDURE WHICH LED TO A 30 MINUTE DELAY. THE PIECE WAS RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9688374 ↗
• MalfunctionFeb 10, 2020Break

  IT WAS REPORTED THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9687743 ↗
• MalfunctionDec 9, 2019Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9438574 ↗
• MalfunctionDec 9, 2019Break

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9438569 ↗
• MalfunctionNov 18, 2019Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE DEVICE BROKE. THE PIECE COULD BE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9336280 ↗
• MalfunctionNov 14, 2019Break

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9322472 ↗
• MalfunctionOct 21, 2019Break

  IT WAS REPORTED THAT THE TIP BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9214838 ↗
• MalfunctionJan 29, 2019Break

  IT WAS REPORTED THAT THE PRODUCT BROKE DURING THE PROCEDURE. ALL PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286379 ↗
• MalfunctionOct 18, 2018Break

  IT WAS REPORTED THAT THE TIP BROKE. ALL PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7981107 ↗