Drills DRILL-1.6/095CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842188109607), received between Feb 9, 2018 and Jul 31, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Break; Break

  SALES REP REPORTED ON (B)(6) 2023 THAT WHEN THE SURGEON WAS DRILLING INTO THE PATIENT'S BONE, THE TIP OF DRILL-1.6/095C STARTED TO SPLIT. IT WAS REPORTED THAT THE SURGEON MADE IT INTO JUST A SMALL PORTION OF THE BONE BEFORE NOTICING SOMETHING DID NOT SEEM RIGHT. IT WAS ALSO STATED THAT THE PATIENT HAD GOOD BONE QUALITY AND THE PROPER TECHNIQUE WAS BEING FOLLOWED. THE INCIDENT CAUSED A 45-MINUTE DELAY IN SURGERY AS THE SURGEON ATTEMPTED TO REMOVE THE DRILL BITS, HOWEVER THEY WERE IMBEDDED IN THE SCAPHOID AND THEY COULD NOT FIND THEM. THE REP REPORTED THERE ARE 4 PIECES OF THE DRILL LEFT IN THE PATIENT WHICH COULD LEAD TO COMPLICATIONS IN THE FUTURE IF ANY OF THE PIECES ARE OUTSIDE OF THE SCAPHOID WHICH COULD DAMAGE THE SURROUNDING SOFT TISSUE. X-RAYS AND A PICTURE WERE PROVIDED HOWEVER THE REMAINDER OF THE DRILL WAS DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17427172 ↗
• MalfunctionFeb 9, 2018Device Issue; Device Issue

  DURING SURGERY ON (B)(6) 2017, A SURGEON INSERTED DRILL-1.6/095 (LOT#196758) OVER A BENT K-WIRE, AND THE DRILL SPLIT OPEN AT THE BEND IN K-WIRE, OUTSIDE THE BONE. THE DRILL AND K-WIRE WERE REMOVED, AND THE REP CONFIRMED THAT THERE WERE NO BROKEN PIECES OR DEBRIS CREATED FROM THE DRILL SPLITTING. THIS IS THE FIRST OCCURRENCE OF THIS KIND FOR THIS TYPE OF PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7260133 ↗