NA 324.215Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982191298), received between Jan 22, 2019 and Nov 19, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE PROCEDURE 2.5 GUIDE IS LOCKED IN THE CENTERING GUIDE AND IT WAS NOT POSSIBLE TO REMOVE IT LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593977 ↗
• MalfunctionJul 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WIRE GUIDE SHOULD BE CONICAL, BUT INSIDE THE WIRE GUIDE IS A STEP SO THAT THE 2.5 WIRE IS HARD TO PASS THROUGH THE CANNULATION. THIS WAS FOUND WHEN THE SET WAS BUILT; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468796 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, IN STERILE PROCESSING, THE DEVICES WERE FOUND TO BE STRIPPED AND NOT THREADING PROPERLY INTO THE HANDLES. THEY ARE NOT LOCKING INTO THE GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.5 PERC WIRE GUIDE F/5.0 LCKNG SCREWS. THIS IS REPORT 6 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320549 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, IN STERILE PROCESSING, THE DEVICES WERE FOUND TO BE STRIPPED AND NOT THREADING PROPERLY INTO THE HANDLES. THEY ARE NOT LOCKING INTO THE GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.5 PERC WIRE GUIDE F/5.0 LCKNG SCREWS. THIS IS REPORT 5 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320519 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, IN STERILE PROCESSING, THE DEVICES WERE FOUND TO BE STRIPPED AND NOT THREADING PROPERLY INTO THE HANDLES. THEY ARE NOT LOCKING INTO THE GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.5 PERC WIRE GUIDE F/5.0 LCKNG SCREWS. THIS IS REPORT 4 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320494 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION, IN STERILE PROCESSING, THE DEVICES WERE FOUND TO BE STRIPPED AND NOT THREADING PROPERLY INTO THE HANDLES. THEY ARE NOT LOCKING INTO THE GUIDE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS. THIS IS REPORT 1 OF 8 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319954 ↗
• MalfunctionApr 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION/INTERNAL FIXATION PROCEDURE ON (B)(6) 2023, THE SURGEON WAS THREADING THE H&LE FOR PERCUTANEOUS THRD DRILL GUIDES INTO THE THREADED DRILL GUIDES, AND THE HANDLE FOR PERCUTANEOUS THREADED DRILL GUIDES WOULD THREAD BUT NOT RETAIN THE RIGIDNESS THAT THE SURGEON WAS USED TO ACHIEVING. THE SURGERY WAS DELAYED BY FOUR MINUTES DUE TO THE EVENT. A SECOND SET OF INSTRUMENTS WAS OPENED IN ORDER TO OBTAIN ANOTHER PERCUTANEOUS THREADED DRILL GUIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762293 ↗
• MalfunctionDec 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE HEXAGONAL PIN WRENCH WAS REPORTED TO NOT FIT THE INSTRUMENTS THAT IT WAS SUPPOSED TO. THE PIN WRENCH IS ALTERED SO THAT IT CAN BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938382 ↗
• MalfunctionJan 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.5MM WIRE GUIDES AND 4.3MM DRILL GUIDES FOR OUR 4.5MM VA CURVED CONDYLAR SETS WERE MADE INCORRECTLY. THE HEXAGONAL KEY COULD NOT FIT INTO THE SMALL HOLES IN THE SLEEVES. THERE ARE FOUR (4) OF EACH SLEEVE FOR A TOTAL OF EIGHT (8). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8267321 ↗
• MalfunctionJan 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.5MM WIRE GUIDES AND 4.3MM DRILL GUIDES FOR OUR 4.5MM VA CURVED CONDYLAR SETS WERE MADE INCORRECTLY. THE HEXAGONAL KEY COULD NOT FIT INTO THE SMALL HOLES IN THE SLEEVES. THERE ARE FOUR (4) OF EACH SLEEVE FOR A TOTAL OF EIGHT (8). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8267301 ↗
• MalfunctionJan 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.5MM WIRE GUIDES AND 4.3MM DRILL GUIDES FOR OUR 4.5MM VA CURVED CONDYLAR SETS WERE MADE INCORRECTLY. THE HEXAGONAL KEY COULD NOT FIT INTO THE SMALL HOLES IN THE SLEEVES. THERE ARE FOUR (4) OF EACH SLEEVE FOR A TOTAL OF EIGHT (8). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8267283 ↗
• MalfunctionJan 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.5MM WIRE GUIDES AND 4.3MM DRILL GUIDES FOR OUR 4.5MM VA CURVED CONDYLAR SETS WERE MADE INCORRECTLY. THE HEXAGONAL KEY COULD NOT FIT INTO THE SMALL HOLES IN THE SLEEVES. THERE ARE FOUR (4) OF EACH SLEEVE FOR A TOTAL OF EIGHT (8). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.5MM PERCUTANEOUS WIRE GUIDE F/5.0MM LCKNG SCREWS. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8267277 ↗