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Drills DRILL-4.0/220CRecalls & reported problems

Trimed, INC. · Drill 4.0, 220mm Cannulated · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842188109676), received between Aug 11, 2017 and Aug 31, 2018 — 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 16, 2026.

Most reported problems

Device problems

  • Break3

Patient problems

  • No Consequences Or Impact To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 31, 2018Break; Break

    TRIMED RECEIVED THE FOLLOWING REPORT ON (B)(6) 2018 FROM TRIMED SALES MEMBER LOCATED IN THE UNITED STATES, REGARDING THE DRILL 4.0, 220MM CANNULATED: DURING AN INTRA-OPERATIVE PROCEDURE, IT WAS DISCOVERED THAT THE DRILL 4.0, 220MM CANNULATED (DRILL-4.0/220C) HAD MALFUNCTIONED. THE SURGEON USED A REPLACEMENT DRILL WHICH HAD THE SAME OUTCOME. THE SURGEON THEN USED A THIRD DRILL TO SUCCESSFULLY COMPLETE THE SURGERY. THIS INCIDENT DID NOT CAUSE ANY FURTHER HARM TO THE PATIENT. THIS IS THE FIRST TIME THIS TYPE OF MALFUNCTION HAS BEEN REPORTED, FOR THE DRILL-4.0/220C, TO TRIMED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7838819 ↗
  • MalfunctionAug 31, 2018Break; Break

    TRIMED RECEIVED THE FOLLOWING REPORT ON (B)(6) 2018 FROM TRIMED SALES MEMBER LOCATED IN THE UNITED STATES, REGARDING THE DRILL 4.0, 220MM CANNULATED: DURING AN INTRA-OPERATIVE PROCEDURE, IT WAS DISCOVERED THAT THE DRILL 4.0, 220MM CANNULATED (DRILL-4.0/220C) HAD MALFUNCTIONED. THE SURGEON USED A REPLACEMENT DRILL WHICH HAD THE SAME OUTCOME. THE SURGEON THEN USED A THIRD DRILL TO SUCCESSFULLY COMPLETE THE SURGERY. THIS INCIDENT DID NOT CAUSE ANY FURTHER HARM TO THE PATIENT. THIS IS THE FIRST TIME THIS TYPE OF MALFUNCTION HAS BEEN REPORTED, FOR THE DRILL-4.0/220C, TO TRIMED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7838818 ↗
  • MalfunctionAug 11, 2017Break; Break

    THE DRILL WAS INSERTED OVER K WIRE AND WAS USED TO DRILL BEYOND THE FRACTURE LOCATION, THE DISTAL TIP OF THE DRILL BROKE. THE PART PERFORMED AS EXPECTED PRIOR TO BREAKAGE. THE SURGEON WAS ABLE TO USE MULTIPLE INSTRUMENTS TO RETRIEVE APPROXIMATELY 5 LOOSE FRAGMENTS FROM THE MEDULLARY CANAL. ALL PIECES OF THE PART WERE EXTRACTED FROM THE PATIENT, WITH NO COMPLICATIONS REPORTED TO DATE. THE PRODUCT REP STATES "DURING THE LAST CONVERSATION WITH THE SURGEON, THERE WERE NO ISSUES".

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6788542 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

Sources and updates

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