LCP 313.353Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982188182), received between May 21, 2020 and Feb 29, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 14, 2024, THE FOLLOWING ISSUES WERE NOTED: THE MEASURING DEVICE TIP IS BENT AND UNUSABLE. THE BENDING IRONS ARE ALSO BENT AND UNUSABLE. DRILL TOWER THREADS ARE CROSS-THREADED AND WILL NOT STAY IN THE PLATE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.0MM LCP SOLID THREADED DRILL GUIDE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810382 ↗
• MalfunctionFeb 29, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE FOLLOWING ISSUES WERE NOTED: THE MEASURING DEVICE TIP IS BENT AND UNUSABLE. THE BENDING IRONS ARE ALSO BENT AND UNUSABLE. DRILL TOWER THREADS ARE CROSS-THREADED AND WILL NOT STAY IN THE PLATE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.0MM LCP SOLID THREADED DRILL GUIDE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18810376 ↗
• MalfunctionSep 14, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE DEVICE IS BROKEN. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1)DRILLSL 2.7 F/AIM ARM NO. 313.354 F/DHP THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17746546 ↗
• MalfunctionMay 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE WHILE THE SURGEON WAS DRILLING THROUGH THE DRILL GUIDE AND DROPPED HIS HAND TO CREATE AN UNDESIRABLE ANGLE, THE UNKNOWN DRILL BIT BROKE OFF AND WAS COLD-WELDED IN THE DRILL GUIDE. HOWEVER, THE DRILL GUIDE WAS REMOVED AND THE UNKNOWN DRILL BIT WAS COLD-WELDED IN THE DRILL GUIDE. THE SCREWDRIVER BLADE WITH HOLDING SLEEVE WAS ALSO DAMAGED DURING THE SURGERY. THE STAR END OF THE SHAFT WAS TWISTED. THE SURGEON MUST HAVE OVER TORQUED IT. THERE WAS NO SURGICAL DELAY. ANOTHER UNKNOWN DRILL GUIDE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE IS NO KNOWN PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) 2.0MM LCP SOLID THREADED DRILL GUIDE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10080809 ↗