DJO SURGICAL 801-05-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446238898), received between Dec 17, 2021 and Dec 14, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K171991); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2022Device Handling Problem; Device Handling Problem

  INSTRUMENT FAILURE: DUE TO THE LOCKING TIBIAL IMPACTORS AT NEBH KEEP COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980317 ↗
• MalfunctionDec 14, 2022Device Handling Problem; Device Handling Problem

  INSTRUMENT FAILURE: DUE TO THE LOCKING TIBIAL IMPACTORS AT NEBH KEEP COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979852 ↗
• MalfunctionDec 14, 2022Device Handling Problem; Device Handling Problem

  INSTRUMENT FAILURE: DUE TO THE LOCKING TIBIAL IMPACTORS AT NEBH KEEP COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979734 ↗
• MalfunctionDec 14, 2022Device Handling Problem; Device Handling Problem

  INSTRUMENT FAILURE: DUE TO THE LOCKING TIBIAL IMPACTORS AT NEBH KEEP COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979731 ↗
• MalfunctionDec 14, 2022Device Handling Problem; Device Handling Problem

  INSTRUMENT FAILURE: DUE TO THE LOCKING TIBIAL IMPACTORS AT NEBH KEEP COMING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979730 ↗
• MalfunctionJan 12, 2022Device Handling Problem; Break; Device Handling Problem

  INSTRUMENT FAILURE - DUE TO THE LOCKING TIBIAL IMPACTORS AT NEBH KEEP COMING APART.

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

  MAUDE report 13237928 ↗
• MalfunctionDec 17, 2021Detachment of Device or Device Component

  INSTRUMENT FAILURE - BLACK PLASTIC PIECE OF TIBIAL IMPACTOR (ON SPRING PART) CONSTANTLY FALLS OFF DURING STERILIZATION, STERILE PROCESSING DEPARTMENTS CONSTANTLY LOSE PIECE. DOES NOT HAPPEN DURING SURGERY, PROBLEM IS DURING STERILIZATION ESPECIALLY AFTER CASES THE PIECE FALLS OFF DUE TO EXPANDING FROM HEAT AND STERILE PROCESSING DEPARTMENTS LOSE THE PIECE BEFORE TRAYS ARE PUT BACK TOGETHER AND PICKED UP.

  Patient problems: Insufficient Information

  MAUDE report 13030249 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171991. One submission often covers many models, so check the product and lot details in each record.

• Z-0508-2024 · Nov 10, 2023 · Open, Classified
  DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108
• Z-0258-2024 · Sep 29, 2023 · Open, Classified
  DJO EMPOWR Knee Punch Handle, REF: 801-05-040
• Z-0060-2021 · Aug 3, 2020 · Open, Classified
  DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conj