NA 72203855Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554030112), received between Feb 13, 2020 and Feb 24, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A BANKART (LABRUM) REPAIR, THE DOCTOR DRILLED A FIRST BONE HOLE AT 5 O'CLOCK AND PUT THE 1ST ANCHOR IN WITH NO COMPLICATIONS. THEN, WHEN DRILLING THE SECOND BONE HOLE AT 4 O'CLOCK ON THE GLENOID WITH THE 1.7MM TWIST DRILL (S), THEY REALIZED IT WAS DIFFICULT TO BOTTOMING OUT THE DRILL. THEREFORE, THEY TOOK THE DRILL OUT OF THE GUIDE AND REALIZED THAT THE DRILL THEY WERE USING WAS ACTUALLY AN XL LENGTH DRILL BIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE CORRECT DRILL BIT FROM THE SAME BOX. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9745620 ↗
• MalfunctionFeb 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A SUB-PEC TENODESIS, WHEN DRILLING IT WAS NOTICED THAT THE LENGTH OF THE TWIST DRILL BIT WAS LONGER THAN IT USUALLY IS. WHEN HITTING THE FAR CORTEX, AND THE DRILL LOOKED TO BE ABNORMALLY LONG, THE SURGEON STOPPED DRILLING ANY FARTHER. ANOTHER DRILL BIT WAS OPENED UP AND THE DIFFERENCE WAS NOTICEABLE. THE DRILL HOLE WAS USED TO IMPLANT THE ANCHOR WITH NO ISSUES. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT INJURED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720504 ↗
• MalfunctionFeb 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, WHEN SURGEON WENT TO DRILL AN ANCHOR AND BEFORE SPINNING THE DRILL, HE NOTICED IT SEEMED LONGER THAN NORMAL HOWEVER HE ALREADY USED IT WITH THE FIRST ANCHOR. HE PULLED THE GUIDE OUT AND SURE ENOUGH, THE DRILL BIT WAS WAY LONGER THAN THE DRILL GUIDE AND COMPARING WITH OTHER DRILLS THERE WAS A VISIBLE DIFFERENCE WITH THE LENGTH SIDE BY SIDE. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9706810 ↗