NA 211113Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705001583), received between Aug 20, 2018 and Sep 20, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (3 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. How this data works · Data updated Oct 13, 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 20, 2022Degraded; Use of Device Problem; Degraded; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW, IT WAS OBSERVED THAT THE DRILL BIT SUPER/RC/GLS 2.9 MM DEVICE WAS DULL AND DID NOT WORK PROPERLY. 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 15458152 ↗
• MalfunctionApr 16, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE DRILL BIT DEVICE WAS DULL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679632 ↗
• MalfunctionJul 24, 2020Degraded; Dull, Blunt; Degraded; Dull, Blunt

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2020, THE DRILL BIT SUPER/RC/GLS 2.9 MM WAS FOUND DULL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319297 ↗
• MalfunctionJun 23, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY SALES REP VIA COMPLAINT SUBMISSION TOOL THAT PRE-OPERATIVELY TO A TENDON REPAIR, A DRILL BIT SUPER/RC/GLS 2.9 MM WAS BENT. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE AND THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184215 ↗
• MalfunctionSep 18, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE TIP OF THE CUSTOMER'S SUPER / RC DRILL BIT 2.9 MM BROKE OFF WHILE DRILLING A BONE HOLE IN A ROTATOR CUFF REPAIR PROCEDURE. ALL PIECES OF THE BROKEN DRILL BIT WERE REMOVED FROM THE PATIENT. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH A THREE TO FIVE MINUTE DELAY AND NO PATIENT CONSEQUENCE. THE CUSTOMER REPORTED TO THE SALES REP THAT THEY MAY HAVE BEEN A LITTLE OFF AXIS WHILE DRILLING INTO A LITTLE HARD BONE. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9084771 ↗
• MalfunctionAug 20, 2018Break; Break

  THE INVENTORY MANAGER FOR ARTHROSOURCE REPORTED THAT WHILE GOING THROUGH THEIR EQUIPMENT THEY FOUND THEIR SUPER ANCHOR DRILL BIT HAD A BROKEN TIP. THE MANAGER VERIFIED THAT THE DEVICE WAS NOT USED IN A PROCEDURE AND THERE WERE NO PATIENT CONSEQUENCES. THE INVENTORY MANAGER STATED THAT THE DEVICE WAS OVER 2 YEARS OLD AND HAD SEEN HEAVY USE. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800144 ↗