GII 213207Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705002610), received between Jul 23, 2018 and Sep 13, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 23, 2018Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 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 7711367 ↗