NA 03.130.325Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982075659), received between Jul 28, 2020 and Jul 31, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 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.

• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRONGS OF TISSUE PROTECTOR WERE MESSED UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677733 ↗
• MalfunctionMar 5, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM NEW ZEALAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 DURING A HAND CASE, THE DRILL GUIDE WAS DISCOVERED TO BE DAMAGED WHEN THE SET WAS OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0/1.5MM DOUBLE DRILL SLEEVE FOR 2.0MM CORTEX SCREWS/BLUE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836416 ↗
• MalfunctionSep 23, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THAT THE DOUBLE DRILL GUIDE IS BROKEN OFF DURING SURGERY. NO PATIENT HARM REPORTED NOR SIGNIFICANT DELAY. THIS REPORT IS FOR ONE (1) DOUBLEDRILLGUIDE 2/1.5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471719 ↗
• MalfunctionMar 31, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL GUIDE IN LOANER SET WAS NOTICED TO BE BENT ON THE 1.5MM SIDE OF THE 2.0/1.5 DRILL GUIDE. THE DRILL GUIDE WAS NOT NEEDED FOR SURGERY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.0/1.5MM DOUBLE DRILL SLEEVE FOR 2.0MM CORTEX SCREWS/BLUE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599631 ↗
• MalfunctionJul 28, 2020Material Deformation; Material Deformation

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED ON (B)(6) 2020, WHEN A NEW VA HANDSET WAS PUT TOGETHER THE DOUBLE DRILL GUIDE WAS FOUND TO BE BENT IN THE PACKAGE. IT IS UNKNOWN WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335685 ↗