NA 6020-17-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295178439), received between Jun 18, 2020 and May 7, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PLASTIC CAP ON THE MALLET IS STRIPPED. IT WILL NOT STAY ON THE MALLET. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317208 ↗
• MalfunctionApr 1, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA BHA WITH THE SLOTTED MALLET IN QUESTION. DURING THE SURGERY, THE RESIN PART OF THE SLOTTED MALLET CAME OFF. THE SURGEON TRIED TO ATTACH THE RESIN PART TO THE SLOTTED MALLET, BUT HE COULDN¿T BECAUSE THE THREAD PART WAS DAMAGED. THE SURGEON USED IT WITHOUT THE RESIN PART IN THE SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER THE SURGERY, THE SALES REP TRIED TO ATTACH THE RESIN PART TO THE SLOTTED MALLET, BUT THE SAME EVENT WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. BECAUSE IT WAS CONFIRMED DURING SURGERY THAT THE THREAD OF THE RESIN PART OF THE SLOTTED MALLET HAD LOOSENED, THE DOCTOR REMOVED THE RESIN PART BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11605432 ↗
• MalfunctionDec 11, 2020Break; Break

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA. IT WAS REPORTED THAT DURING THE SURGERY, THE WHITE PLASTIC PART OF THE MALLET CAME OFF. THERE WAS NO HARMS TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992224 ↗
• 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 10567245 ↗
• MalfunctionJun 18, 2020Break; Break

  THE SURGERY WAS PERFORMED ON (B)(6) 2020. DURING THE SURGERY, THE PLASTIC PART OF THE HUMMER (P/N:602017000) CAME OFF, AND THE SURGEON COULD NOT ATTACH IT TO THE HUMMER. THERE WAS NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10170905 ↗