GIIRecalls & reported problems across all models

We found 4 models of GII by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2018 and Nov 7, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GII problems

GII models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GII 211093

  BIT, DRILL
  12 reports
• GII 213207

  Guide, surgical, instrument
  6 reports
• GII 211502

  BIT, SURGICAL
  2 reports
• GII 214542

  REAMER
  1 report

Recent GII adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE T-HANDLE DID NOT FIT DOWN THE GII REAMER ARTHRO DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13190833 ↗
• MalfunctionSep 13, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING A BICEP TENODESIS PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE GII/SUPER/RC DRGDE SLOT DEVICE AND THE HEALIX ADVANCE 3.5MM DRILL BIT DEVICE WERE WELDED TOGETHER THAT THEY COULD NOT GET APART. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463364 ↗
• MalfunctionDec 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING DECONTAMINATION, IT WAS OBSERVED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LOCK SCREW THAT ATTACHES THE RIGIDFIX ROD WITH THE BONE GUIDE WAS FOUND TO BE BROKEN THAT A LITTLE PORTION OF THE SCREW REMAINED INSIDE THE LOCKING POINT; AND THEREFORE THE DEVICES COULD NOT BE SEPARATED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11065254 ↗
• 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 ↗
• MalfunctionSep 16, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S GII SLOTTED DRILL GUIDE DEVICE 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 FIVE 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. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9071465 ↗
• 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 ↗
• MalfunctionApr 4, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A POSTERIOR TIBIAL TENDON REPAIR PROCEDURE THE GII SLOTTED DRILL GUIDE CREATED METAL SHAVINGS AS THE DRILL BIT WAS BEING PASSED THROUGH. THE SALES REP STATED THAT IT SEEMED THE GUIDE WAS BENT. THE SHAVINGS WERE REMOVED WITH TWEEZERS AND THEN FLUSHED WITH IRRIGATION TUBING, SO THAT NO DEBRIS REMAINED IN THE PATIENT. THE BONE HOLE ORIGINALLY DRILLED FOR THE CASE WAS ABLE TO BE USED. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8484616 ↗
• MalfunctionJan 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SALES REP DURING A DISTAL BICEPS SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GII/SUPER/RC DRGDE SLOT EA DRILL GUIDE DEVICE BROKE AT THE TIP AND SLOT. THERE WERE NO METAL SHAVINGS THAT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER INCIDENT NOR DELAY. 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 8263954 ↗
• 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 ↗

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