NA 03.110.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982071927), received between Feb 1, 2024 and Apr 22, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Break

  DROP IN GUIDE HAS BROKEN AND IS UNUSABLE. GUIDE BLOCKS HAVE ALSO BROKEN WHERE THREADS ARE FOR THE SCREW. ISSUE OCCURRED DURING CONTINUED USE INTRAOPERATIVELY OVER TIME; WAS NOTICED POST-OP DURING REASSEMBLY. DEVICES HAVE BEEN DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957606 ↗
• MalfunctionApr 22, 2026Break

  DROP IN GUIDE HAS BROKEN AND IS UNUSABLE. GUIDE BLOCKS HAVE ALSO BROKEN WHERE THREADS ARE FOR THE SCREW. ISSUE OCCURRED DURING CONTINUED USE INTRAOPERATIVELY OVER TIME; WAS NOTICED POST-OP DURING REASSEMBLY. DEVICES HAVE BEEN DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957598 ↗
• MalfunctionApr 22, 2026Break

  DROP IN GUIDE HAS BROKEN AND IS UNUSABLE. GUIDE BLOCKS HAVE ALSO BROKEN WHERE THREADS ARE FOR THE SCREW. ISSUE OCCURRED DURING CONTINUED USE INTRAOPERATIVELY OVER TIME; WAS NOTICED POST-OP DURING REASSEMBLY. DEVICES HAVE BEEN DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957591 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS WERE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WERE UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1)1.8 DRILL GUIDE MEASURING GUIDE BLOCK. THIS IS REPORT 2 OF 2 FOR COMPLAINT. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839258 ↗
• MalfunctionFeb 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE GUIDE WIRE WAS LOOSE IN THE GUIDE BLOCK FROM USE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE 1.8MM DRILL GUIDE WITH MEASURING FOR GUIDE BLOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624807 ↗