NA 03.122.064Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982074911), received between Nov 1, 2019 and Nov 11, 2019 — classified as 4 malfunctions.

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

• MalfunctionNov 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 AT APPROXIMATELY 4:00PM, THE 2.8MM DRILL SLEEVE WOULD NOT DISENGAGE FROM THE OUTER SLEEVE FOR INSERTING GUIDE. A SURGICAL DELAY OF 3 TO 5 MINUTES HAPPENED, THE PROCEDURE WAS SUCCESSFUL. PATIENT STATUS IS UNKNOWN. THIS IS 2 OF 4 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9306447 ↗
• MalfunctionNov 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 AT APPROXIMATELY 4:00PM, THE 2.8MM DRILL SLEEVE WOULD NOT DISENGAGE FROM THE OUTER SLEEVE FOR INSERTING GUIDE. A SURGICAL DELAY OF 3 TO 5 MINUTES HAPPENED, THE PROCEDURE WAS SUCCESSFUL. PATIENT STATUS IS UNKNOWN. THIS IS 3 OF 4 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9306426 ↗
• MalfunctionNov 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 AT APPROXIMATELY 4:00PM, THE 2.8MM DRILL SLEEVE WOULD NOT DISENGAGE FROM THE OUTER SLEEVE FOR INSERTING GUIDE. A SURGICAL DELAY OF 3 TO 5 MINUTES HAPPENED, THE PROCEDURE WAS SUCCESSFUL. PATIENT STATUS IS UNKNOWN. THIS IS 4 OF 4 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9306424 ↗
• MalfunctionNov 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019 AT APPROXIMATELY 4:00PM, THE OUTER SLEEVE FOR INSERTING GUIDE AND 2.8MM DRILL SLEEVE ARE CURRENTLY NOT WORKING PROPERLY AND THEY ARE NOT MEETING TOGETHER. THE DRILL SLEEVE WOULD NOT DISENGAGE FROM THE OUTER SLEEVE FOR INSERTING GUIDE. SURGICAL DELAY OF THREE (3) TO FIVE (5) MINUTES. THERE WERE NO BACKUP DEVICES USED IN COMPLETING THE PROCEDURE. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9267027 ↗