NA 03.113.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982072863), received between Jan 23, 2023 and Nov 5, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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.

• MalfunctionNov 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. AS TWO PRODUCT RETURNED AS 03.113.020, KINDLY CONFIRM IF BOTH ARE HAVING SAME ALLEGATION? ONLY ONE 03.113.020 WAS RETURNED BY THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479340 ↗
• MalfunctionMar 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE, THE DRILL BIT IN QUESTION GOT COLD WELDED INTO THE PERCUTANEOUS GUIDE IN QUESTION. THERE WAS NO ADVERSE PATIENT IMPACT, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE DRILL SLEEVE WAS TAKEN OFF AND A NEW ONE WAS PUT ON, AND THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979702 ↗
• MalfunctionSep 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT THERE WAS A SCREW COLD WELDED INTO THE NEUTRAL GUIDE AND DRILL BIT STUCK IN THE DRILL GUIDE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: SUCCESSFUL THIS REPORT IS FOR ONE (1)2.8MM PERCUTANEOUS THREADED DRILL GUIDE THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17747610 ↗
• MalfunctionJan 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE THREADS ON THE DRILL GUIDES IN QUESTIONS WERE NOT ABLE TO LOCK INTO THE PLATE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225697 ↗
• MalfunctionJan 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DENMARK REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE THREADS ON THE DRILL GUIDES IN QUESTIONS WERE NOT ABLE TO LOCK INTO THE PLATE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.8MM PERCUTANEOUS THREADED DRILL GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225694 ↗