NA 2421-22-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295122906), received between Dec 10, 2018 and Feb 19, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA THA FOR OA FOR THE HIP JOINT WITH THE PRODUCT IN QUESTION. DURING SURGERY, WHEN THE SURGEON WAS PERFORMING STEM RASPING WITH THE PRODUCT IN QUESTION, THE BASE OF THE HAMMER BROKE. THERE WERE NO BROKEN PARTS LEFT INSIDE THE BODY, AND A DIFFERENT HAMMER WAS USED WITHOUT AFFECTING THE SURGERY. THE SURGEON OPINED THAT THE CAUSE OF THE BREAKAGE WAS LIKELY DUE TO METAL FATIGUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730893 ↗
• MalfunctionNov 1, 2022Break; Break

  IT WAS REPORTED THAT THE WHITE PLASTIC PART OF THE SLOTTED MALLET IN QUESTION WAS FLEW OFF DURING A DRIVING FOR RASP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710538 ↗
• MalfunctionApr 29, 2022Break; Break

  THE HAMMER BROKE INTO TWO PIECES AT THE CONNECTION POINT OF THE HEAD AND THE SHAFT DURING SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14250196 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE ARTIFICIAL BONE HEAD SURGERY WITH THE SLOTTED HAMMER IN QUESTION. DURING THE SURGERY, THE WHITE NYLON PART OF THE HAMMER CAME OFF. THE SURGEON TRIED TO ATTACH THE NYLON PART TO THE HAMMER, BUT HE COULDN¿T. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615340 ↗
• MalfunctionJan 20, 2021Break; Break

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2021 VIA BHA. DURING THE SURGERY, WHEN THE SURGEON IMPACTED A RASP HANDLE WITH THE SLOTTED HAMMER, THE HEAD PART OF THE HAMMER BROKE. THERE WERE NO HARMS TO THE PATIENT, THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11201542 ↗
• MalfunctionSep 22, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  THE SURGERY WAS PERFORMED ON (B)(6) 2020. IT WAS REPORTED THAT THE DEVICE (P/N:242122000 OR P/N: 602017000)¿S PLASTIC TOP HEAD PART CAME OFF. THERE WAS NO INTERFERENCE FOR THE SURGERY AND NO HARM TO THE PATIENT. THE HOSPITAL STAFF TOLD THAT IT SEEMED THAT THE DEVICE¿S PLASTIC PART STRIPPED AND CAME OFF EASILY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10567244 ↗
• MalfunctionFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTRUMENT IS BROKEN, NO IMPACT TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367067 ↗
• MalfunctionDec 10, 2018Component Missing; Component Missing

  IT WAS DISCOVERED THAT THE END CAP SUB-COMPONENT WAS MISSING FROM THE LIGHT SLOTTED MALLET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8146983 ↗