GII 211502Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705001743), received between Apr 8, 2018 and Aug 19, 2018 — 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.

• MalfunctionAug 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S GII SLOTTED DRILL GUIDE WAS BENT CAUSING THEIR GII ARTHO DRILL BIT TO BREAK AT THE DISTAL TIP WHILE THE SURGEON TRIED TO FORCE THE DRILL BIT THROUGH THE GUIDE DURING A BICEP PROCEDURE. IT WAS CONFIRMED NOTHING FELL INSIDE THE PATIENT. THE SURGEON USED ANOTHER DRILL GUIDE AND DRILL BIT TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A 5 MINUTE DELAY. BOTH DEVICES WERE OVER 2 YEARS OLD AND HAD SEEN A LOT OF USE. THE DEVICES WERE ALSO ALREADY DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796246 ↗
• MalfunctionApr 8, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED VIA PHONE BY THE SALES REP, THAT DURING A BICEPS PROCEDURE, THE CUSTOMER'S GII DRILL BIT WOULD NOT ENGAGE IN THE BONE. THEY SWAPPED THE DEVICE WITH ANOTHER LIKE DEVICE FROM THE OTHER SET TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405970 ↗