NA 5983-40-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00889024218277), received between Feb 4, 2021 and Nov 19, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE, THE HEAD OF THE SCREW BROKE OFF IN THE DRIVER. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594094 ↗
• MalfunctionNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT SEVERAL THIN METAL FRAGMENTS WERE FOUND WHEN THE INSERTED SCREW WAS REMOVED WITH A POWER TOOL. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536070 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THE HEAD OF SCREW BROKE OFF IN USE. NO PATIENT HARM OR IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874290 ↗
• MalfunctionFeb 24, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21448405 ↗
• MalfunctionDec 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE ONE OF THE SCREW HEADS FRACTURED. THE HEAD WAS BURRED OUT AND ALL PIECES WERE RETRIEVED. NO PIECES WERE LEFT IN THE PATIENT. IT TOOK ABOUT TWENTY FIVE MINUTES EXTRA BEFORE PROCEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846050 ↗
• MalfunctionMay 21, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19364165 ↗
• MalfunctionAug 10, 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 17498302 ↗
• MalfunctionMar 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE HEAD OF THE SCREW FRACTURED OFF UPON SCREWING IT IN ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13824514 ↗
• MalfunctionSep 27, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS DRILLING THE HEADED SCREW INTO THE FEMORAL CUTTING BLOCK, THE TIP OF THE SCREW CAME OFF. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12536003 ↗
• InjuryJun 3, 2021Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 11931507 ↗
• InjuryFeb 4, 2021Fracture; Fracture

  IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHILE THE SURGEON WAS INSERTING A SCREW INTO THE FEMUR THROUGH THE SPACER BLOCK FEMORAL RESECTOR, THE HEAD OF THE SCREW FRACTURED INSIDE THE INSERTER. THE SURGEON ATTEMPTED TO REMOVE THE SCREW FROM THE DEVICE WITH PLIERS, RESULTING IN A TWENTY-FIVE (25) MINUTE DELAY AND AN ANTERIOR MICRO FRACTURE TO THE PATIENT'S FEMUR. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 11278118 ↗
• InjuryFeb 4, 2021Fracture; Fracture

  IT IS REPORTED THAT DURING KNEE ARTHROPLASTY WHILE THE SURGEON WAS INSERTING A SCREW INTO THE FEMUR THROUGH THE SPACER BLOCK FEMORAL RESECTOR, THE HEAD OF THE SCREW FRACTURED INSIDE THE INSERTER. THE SURGEON ATTEMPTED TO REMOVE THE SCREW FROM THE DEVICE WITH PLIERS, RESULTING IN A TWENTY-FIVE (25) MINUTE DELAY AND AN ANTERIOR MICRO FRACTURE TO THE PATIENT'S FEMUR. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s)

  MAUDE report 11278117 ↗