DJO SURGICAL 800-05-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912408677), received between Sep 21, 2016 and Dec 20, 2019 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2019Break

  INSTRUMENT FAILURE - DRILL BIT SNAPPED DURING AN ANTERIOR RUN OUT TEST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9505849 ↗
• MalfunctionOct 12, 2017Break; Detachment Of Device Component

  INSTRUMENT FAILURE - DUE TO THE PATIENT RECEIVING A TOTAL KNEE ARTHROPLASTY TO CORRECT FOR THE ADVANCED STAGE OSTEOARTHRITIS AND VERY POOR RANGE OF MOTION. DURING THE CASE, THE SURGEON PREFERRED TO PREDRILL THE PIN HOLES USING THE LONG 3.2MM DRILL (CATALOG # 800-05-022) FROM THE EMPOWR KNEE TRAYS. THE REPRESENTATIVE SUGGESTED THE USE OF THE SHORT, HARD STOP 3.2MM DRILL BIT AND WAS OVER RULED BY THE TECHNICIAN. THE INCIDENT HAPPENED WHILE THE HOLES FOR THE TIBIAL BASEPLATE HEADED PINS WERE BEING PREDRILLED. THE MEDIAL HOLE WAS DRILLED AND A HEADED PIN WAS PLACED THROUGH THE BASEPLATE. THEN THE LATERAL HOLE WAS DRILLED THROUGH THE BASEPLATE. THIS IS WHEN THE DRILL BROKE. THE SURGEON CONTINUED TO PREPARE THE TIBIA BY REAMING AND PUNCHING THROUGH THE APPROPRIATE GUIDE. ONCE THIS WAS DONE, THE BASEPLATE WAS REMOVED. THE SURGEON THEN LOOKED INTO THE HOLE WHERE THE DRILL HAD BROKEN OFF INTO. HE DECIDED THAT THE DRILL WAS TOO DEEP INTO THE BONE TO RETRIEVE. THE END RESULT WAS THE DRILL BEING LEFT INTO THE CANCELLOUS BONE OF THE TIBIA AND THE CEMENT MANTLE BEING PLACED PROXIMAL TO IT. THE RESULTS OF THE TOTAL KNEE ARTHROPLASTY WERE SATISFACTORY. THE SURGEON WAS ABLE TO RESTORE MOBILITY TO T

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6943935 ↗
• MalfunctionSep 21, 2016Break

  INSTRUMENT FAILURE/PRIMARY SURGERY. WHILE USING THE 1/8" QUICK CONNECT DRILL TO EVALUATE THE ANTERIOR RESCTION OF THE FEMUR THE TIP OF THE DRILL BIT BROKE OFF IN THE ANTERIOR FEMUR. THE SURGEON DECIDED IT WOULD HAVE BEEN MORE DETRIMENTAL TO THE PATIENT TO TRY AND REMOVE IT AND THE DRILL BIT WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5966278 ↗