GII 211093Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705001576), received between Jul 23, 2018 and Nov 7, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (5 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Degraded; Degraded

  THIS IS REPORT 4 OF 4 OF (B)(4). IT WAS REPORTED THAT 4X GII DRBIT DEVICES WERE BLUNT IN THE THEATER. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496914 ↗
• MalfunctionNov 7, 2025Degraded; Degraded

  THIS IS REPORT 3 OF 4 OF (B)(4). IT WAS REPORTED THAT 4X GII DRBIT DEVICES WERE BLUNT IN THE THEATER. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496877 ↗
• MalfunctionNov 7, 2025Degraded; Degraded

  THIS IS REPORT 2 OF 4 OF (B)(4). IT WAS REPORTED THAT 4X GII DRBIT DEVICES WERE BLUNT IN THE THEATER. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496854 ↗
• MalfunctionNov 7, 2025Degraded; Degraded

  IT WAS REPORTED THAT 4X GII DRBIT DEVICES WERE BLUNT IN THE THEATER. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 4 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496842 ↗
• MalfunctionFeb 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THIS DRILL BIT GII 2.4 MM WAS FOUND BENT BEFORE AN UNKNOWN PROCEDURE. THE SALES REP DOES NOT KNOW THE CAUSE OF THE DAMAGE. THE DEVICE WAS NOT USED IN THE PATIENT AND IT WAS DISCARDED BY THE STAFF. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A SURGICAL DELAY DID NOT OCCUR AND THE CASE WAS COMPLETED WITH AN ALTERNATIVE BACKUP TRAY. THE AFFILIATE ALSO REPORTED SURGICAL INTERVENTION IS NOT REQUIRED AND THE ITEM WAS DISCARDED SO LOT/ SERIAL NUMBERS ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9707628 ↗
• MalfunctionJul 16, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ELBOW PROCEDURE IT WAS FOUND THAT THE TIP OF THEIR DRILL BIT GII 2.4MM IS DULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION OR A LOT NUMBER FOR THE DEVICE AS IT WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793614 ↗
• MalfunctionMay 3, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A BICEP PROCEDURE THE GII DRILL BIT WAS DULL. THE SALES REP STATED THAT THE ISSUE WAS NOTICED WHILE ATTEMPTING TO DRILL THE PATIENT'S BONE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE A LOT NUMBER OR ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577860 ↗
• MalfunctionApr 22, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING AN ELBOW SURGERY PROCEDURE, THE CUSTOMER'S GII DRILL BIT WAS DULL. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS FOR A GII DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8535857 ↗
• MalfunctionDec 28, 2018Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE TWO OF THE CUSTOMER'S GII 2.4MM DRILL BIT DEVICES WERE DULL. THE CASE WAS COMPLETED WITH THE SECOND DEVICE SINCE THERE WERE NO ALTERNATIVE DEVICES AVAILABLE. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR EITHER DEVICE. THE DEVICES WERE DISCARDED BY THE CUSTOMER. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8204106 ↗
• MalfunctionDec 28, 2018Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE TWO OF THE CUSTOMER'S GII 2.4MM DRILL BIT DEVICES WERE DULL. THE CASE WAS COMPLETED WITH THE SECOND DEVICE SINCE THERE WERE NO ALTERNATIVE DEVICES AVAILABLE. THERE WAS NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR EITHER DEVICE. THE DEVICES WERE DISCARDED BY THE CUSTOMER. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8204098 ↗
• MalfunctionOct 9, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DRILL BIT DEVICE WAS BROKEN. IT WAS REPORTED THAT A SPARE ONE HAS BEEN USED TO COMPLETE THE PROCEDURE. THERE WAS 2/3 MINUTE OF DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946294 ↗
• MalfunctionJul 23, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE HOSPITAL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT UPON USING THE DRILL BIT IN CONJUNCTION WITH THE DRILL GUIDE THE DRILL BIT LOCKED UP IN THE DRILL GUIDE WHICH BROKE THE HANDLE. THE DRILL BIT WAS STILL USABLE EVEN WITH THE DRILL GUIDE SHAFT CONNECTED TO IT TO COMPLETE HOLE DRILLING. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7711369 ↗