MORELAND 2422-04-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295123033), received between Sep 20, 2017 and Feb 5, 2026 — classified as 1 injury, 10 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break

  SNAPPED DURING CASE WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> UNKNOWN, WERE FRAGMENTS GENERATED? --> UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272378 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT DURING STEM EXTRACTION T-HANDLE BROKE OFF, NO ADDITIONAL TIME ADD, NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876884 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT DURING EXPLANATION, THE TOP T HANDLE BROKE ON THE EXTRACTION SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350669 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. B. PLEASE CONFIRM WHEN THE EVENT OCCURRED? POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304756 ↗
• MalfunctionJun 7, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081923 ↗
• MalfunctionNov 2, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THE IMPACTOR HANDLE IS BROKEN. INSTRUMENTS ARE WORN AND UNABLE TO BE ASSEMBLED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715085 ↗
• MalfunctionFeb 3, 2022Break; Break

  ITEMS ARE BROKEN.

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

  MAUDE report 13446578 ↗
• MalfunctionJun 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EXTRACTOR SHAFT WOULD NOT CONNECT TO THE SLAP HAMMER. WHEN SLAPPING BACK BOTH ITEMS WOULD DISCONNECT. THERE WERE NO PATIENT CONSEQUENCES. 30 MINUTE DELAY IN PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11967913 ↗
• MalfunctionJun 2, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  VARIOUS ITEMS HAVE BEEN IDENTIFIED AS NEEDING TO BE REPLACED DUE TO WEAR AND TEAR. NO IMPACT TO PATIENT BUT THESE ARE NO LONGER VIABLE TO USE AND NEED TO BE REPLACED FOR AN UPCOMING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920750 ↗
• InjuryJul 9, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  TODAY DURING SURGERY THE SURGEON IN (B)(6) NEEDED TO USE THIS INSTRUMENT. ON ATTEMPT TO PUT THIS TOGETHER HE FELT THE INSTRUMENT WAS WEAK AT THE TOP AND DID NOT BELIEVE THE THREADS TO BE FITTING TOGETHER PROPERLY. THE TWO PARTS OF THE SLAP HAMMER THAT WOULD NOT FIT TOGETHER ARE BELOW. IN ADDITION DUE TO THIS PROBLEM HE WAS NOT ABLE TO REMOVE A STEM IN SITU, AND THE SURGERY WAS EXTENDED FOR 2 HOURS WHILE WE GOT ANOTHER EXTRACTION KIT FROM A LOCAL HOSPITAL. WHEN USING THE SAME ITEM FROM THE NEW KIT THE STEM CAME STRAIGHT OUT. DURING SURGERY TODAY WHEN USING THE SLAP HAMMER, ON REMOVAL OF THE STEM THE STEM WOULD NOT COME OFF THE END OF THE SLAP HAMMER. THEY SEEMED "WELDED" TOGETHER. THE SURGEON WAS UNHAPPY WITH THIS AND DEEMED IT TO BE A FAULT OF THE SLAP HAMMER. IN ADDITION HE FELT THAT THIS ITEM WAS WEAK IN REMOVING THE CONSTRUCT AND BELIEVED THE THREADS TO CROSS IF THE SLAP HAMMER WAS USED TOO VIGOROUSLY, WHICH IS THE NATURE OF THE TOOL BEING USED.

  Patient problems: No Code Available

  MAUDE report 7670414 ↗
• MalfunctionSep 20, 2017Break; Break

  IT WAS REPORTED THAT THE WELD BROKE AT HANDLE AND SOME THREADS BROKE OFF.

  Patient problems: No Information

  MAUDE report 6879753 ↗