NA 2421-08-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295122784), received between Aug 4, 2017 and Apr 20, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT OSTEOTOME WAS BROKEN DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY AND NEEDED A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925294 ↗
• MalfunctionMay 2, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE DEVICES WERE CHIPPED AND CRACKED. IT DIDN'T HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954622 ↗
• MalfunctionOct 1, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PRODUCT IS DULL AND NEEDS REPLACED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20342653 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS CHIPPED.

  Patient problems: Insufficient Information

  MAUDE report 19566634 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT OSTEOTOME BROKE DURING CEMENT EXTRACTION.

  Patient problems: Insufficient Information

  MAUDE report 17834069 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT THE OSTEOTOME SPLIT INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159560 ↗
• MalfunctionDec 1, 2021Break; Break

  BROKEN MOORLAND INST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908390 ↗
• MalfunctionNov 19, 2021Break; Break

  IT WAS REPORTED THAT THE END BROKE OFF. NOTHING WAS LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12845322 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE OSTEOTOME BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788760 ↗
• MalfunctionJan 29, 2021Break; Break

  THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 (THE EXPLANTED UKA IMPLANTS WERE ANOTHER COMPANY'S PRODUCT). DURING THE SURGERY, THE SURGEON USED MORELAND DEVISES, THE TIP OF CHISEL BROKE. THE SURGEON CHECKED NO FRAGMENT IN THE BODY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254372 ↗
• MalfunctionApr 6, 2020Break; Break

  THE TWO V-SHAPED OSTEOTOMES IN THE OFFICE MORELAND SET ARE BROKEN AND UNUSABLE. THIS SET WAS DELIVERED THIS WAY AS LOANERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9929482 ↗
• MalfunctionDec 4, 2019Break; Break

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN OFF AND CAN NO LONGER BE USED. NOTHING LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9412407 ↗
• MalfunctionApr 25, 2019Break; Material Deformation; Material Twisted/Bent; Break; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENT WAS DISCOVERED TO BE INOPERABLE BEFORE THE PATIENT WAS IN ROOM, PRIOR TO SURGERY STARTING. UPON INSPECTION OF THE INSTRUMENT, IT WAS NOTICED THE TIPS WERE FRACTURED AND THE INSTRUMENT WAS PASSED OFF STERILE FIELD BEFORE PATIENT ARRIVED ON OPERATING ROOM. THE DECISION WAS MADE NOT TO USE INSTRUMENT. NO PIECES OF INSTRUMENT LEFT IN PATIENT, NO SURGERY DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8552124 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT THE TIPS OF THE INSTRUMENTS WERE WORN AND NEED REPLACING. THERE WERE NO BROKEN PARTS, NO BROKEN PIECES AND NO INSTRUMENTS LEFT IN THE PATIENT. EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED WORN CONDITION. ADDITIONALLY, THE INVESTIGATION IDENTIFIED THE DEVICE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432346 ↗
• MalfunctionMar 11, 2019Break; Dull, Blunt; Break; Dull, Blunt

  IT WAS REPORTED THAT THE TIP IS DULL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407416 ↗
• MalfunctionMay 31, 2018Break; Break

  IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT IS CHIPPED AND THE SURGEON WOULD LIKE FOR IT TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556319 ↗
• MalfunctionMay 14, 2018Break; Break

  IT WAS REPORTED THAT THE 3 INSTRUMENTS WERE DAMAGED WHILE TAKING OUT IMPLANTS. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7512094 ↗
• MalfunctionNov 16, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE KNEE EXTRACTION INSTRUMENTS WERE EITHER CHIPPED OR DULL AND THE SURGEON ASKED FOR THEM TO BE REPLACED.

  Patient problems: No Information

  MAUDE report 7039698 ↗
• MalfunctionAug 4, 2017Break; Break

  IT WAS REPORTED THAT THE V CHISEL BROKE WHILE REMOVING THE CEMENT.

  Patient problems: No Information

  MAUDE report 6767028 ↗