NA 211513Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705001750), received between Aug 17, 2018 and Apr 2, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING ORTHOPEDIC PROCEDURE THE SUPER/RC DRBIT ARTHRO 2.9 MM DID NOT PUNCH THROUGH BONE AS EASILY AS WOULD LIKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL BIT. NO PATIENT CONSEQUENCES. THERE WAS A SURGICAL DELAY OF 1 MINUTE REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9917805 ↗
• MalfunctionMar 9, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING A SHOULDER STABILIZATION THE TIP OF THE SUPER/RC DRBIT ARTHRO 2.9MM WAS SLIGHTLY BENT. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED A SURGICAL DELAY WAS NOT REPORTED. IT WAS ALSO REPORTED THE CASE WAS SUCCESSFULLY COMPLETED WITH THE SAME DRILL BIT. THE AFFILIATE REPORTED THE DRILL BIT WAS ¿BLUNT¿ AS SUCH, BUT JUST SLIGHTLY BENT ON THE TIP. IT WAS NOT SIGNIFICANT ENOUGH FOR THE SURGEON TO SWITCH TO A REPLACEMENT DRILL BIT DURING THE CASE, BUT RATHER JUST REQUESTED IT BE REPLACED FOR NEXT TIME. IT WAS REPORTED THE LOT NUMBER WAS UNKNOWN AND THE PRODUCT IS AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808953 ↗
• MalfunctionAug 17, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT TWO OF HIS SUPER/RC DRILL BITS WERE DULL AND WOULD NOT GO THROUGH THE BONE DURING A SHOULDER PROCEDURE. THE DOCTOR USED ANOTHER 2.9 DRILL BIT AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE CUSTOMER DISCARDED BOTH DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793313 ↗
• MalfunctionAug 17, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT TWO OF HIS SUPER/RC DRILL BITS WERE DULL AND WOULD NOT GO THROUGH THE BONE DURING A SHOULDER PROCEDURE. THE DOCTOR USED ANOTHER 2.9 DRILL BIT AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE CUSTOMER DISCARDED BOTH DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793308 ↗