NA 1336-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024186262), received between Nov 23, 2020 and Mar 19, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 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 16, 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.

• MalfunctionMar 19, 2026Fracture

  IT WAS REPORTED THAT DURING IMPACTING WITH A FEMORAL IMPACTOR, THE SCREW-ON ATTACHMENT (WHITE TIP) BROKE IN HALF. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640647 ↗
• MalfunctionDec 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING CLEANING AND INSPECTION, A PIECE OF THE IMPACTOR PAD WAS FOUND TO BE MISSING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826354 ↗
• MalfunctionSep 27, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824136 ↗
• MalfunctionAug 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCESS OF DISASSEMBLING THE IMPACTOR FOR CLEANING, IT WAS DISCOVERED THAT THE IMPACTOR TIP WAS BROKEN OFF INSIDE THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480201 ↗
• MalfunctionJun 23, 2023Fracture; Fracture

  IT WAS REPORTED THE IMPACTOR FRACTURED DURING USE AS PART OF A KNEE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190082 ↗
• MalfunctionMar 15, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546642 ↗
• MalfunctionJul 5, 2022Fracture; Fracture

  IT WAS REPORTED THE THREAD HAS FRACTURED OFF THE FEMUR IMPACTOR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915309 ↗
• MalfunctionMay 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT A FRACTURED IMPACTOR WAS DISCOVERED DURING THE CLEANING PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398189 ↗
• MalfunctionJul 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, THE TIP OF THE INSTRUMENT BROKE OFF. AN ADDITIONAL IMPACTOR WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210818 ↗
• MalfunctionJun 29, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085281 ↗
• MalfunctionNov 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR HEAD BROKE OFF UPON IMPACTION OF THE FEMORAL COMPONENT DURING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10887031 ↗