LCP 323.500Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982190864), received between Oct 3, 2018 and Sep 20, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRILL BIT WAS MISSING. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267656 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024 THAT (323.500) DRILL GUIDE CAP WAS BROKEN, CAN NOT LOCATE, WILL NOT FUNCTION WITHOUT, BELONGS TO TOMOFIX AND DO NOT HAVE A SUBSTITUTE. (310.990) COUNTERSINK IS RUSTED, NOT DAMAGED OR CHIPPED. RUST IS BECOMING MORE PROMINENT. (03.045.022) 4.2 DRILLBIT HAS NOT BEEN USED BUT ARE RUSTED. ALL ITEMS HAVE BEEN FOUND, AND HAVE NOT BEEN USED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LCP UNIV-DRILL-GUIDE 4.5/5 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617965 ↗
• MalfunctionFeb 10, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON JANUARY 19,2023, THAT THE WALL OF DRILL GUIDE HAS TWISTED AND SNAPPED. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) LCP UNIV-DRILL-GUIDE 4.5/5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16352557 ↗
• MalfunctionFeb 9, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343323 ↗
• MalfunctionFeb 9, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE. THIS IS REPORT 6 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342381 ↗
• MalfunctionFeb 9, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE. THIS IS REPORT 5 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342353 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION, THE DRILL GUIDE WAS OBSERVED BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9813574 ↗
• MalfunctionOct 17, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE LOCKING COMPRESSION PLATE (LCP) UNIVERSAL DRILL SLEEVE WAS NOTICED TO BE BENT AND DAMAGED WHEN CLEANING THE INSTRUMENT AND PUTTING THE TOMOFIX SET BACK TOGETHER. THE DRILL SLEEVE AND THE SPINDLE THAT GOES AROUND THE SPRING-LOADED AREA HAS THREADED CUT DUE TO THE MULTIPLE USE. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) 5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7974715 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING ROUTINE INSPECTION, A UNIVERSAL DRILL SLEEVE WAS MISSING THE DRILL BIT AND CAP. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR A UNIVERSAL DRILL SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7930787 ↗