LCP 03.113.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982072764), received between Sep 22, 2021 and Apr 23, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Device-Device Incompatibility

  THE OUTER SLEEVE WAS DIFFICULT TO REMOVE FROM THE AIMING GUIDE, POSTOPERATIVELY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965665 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024, DURING A PHILOS PROX HUMERUS WITH AIMING ARM, SLEEVE WAS DISENGAGING AND NOT CLICKING. TWO OF THEM WERE BROKEN ALONG WITH DEPTH GAUGE BENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1OUTER SLEEVE F/3.5 LCP PERC INST SYS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999489 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2024, DURING A PHILOS PROX HUMERUS WITH AIMING ARM, SLEEVE WAS DISENGAGING AND NOT CLICKING. TWO OF THEM WERE BROKEN ALONG WITH DEPTH GAUGE BENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) OUTER SLEEVE F/3.5 LCP PERC INST SYS THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996571 ↗
• MalfunctionSep 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE AIMING ARM SLEEVES WERE NOT ABLE TO BE REMOVED FROM THE AIMING ARM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797269 ↗
• MalfunctionSep 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE AIMING ARM SLEEVES WERE NOT ABLE TO BE REMOVED FROM THE AIMING ARM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797268 ↗
• MalfunctionSep 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE AIMING ARM SLEEVES WERE NOT ABLE TO BE REMOVED FROM THE AIMING ARM. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797267 ↗
• MalfunctionAug 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON ROUTINE INSPECTION OF THE METRO OFFICE INVENTORY, IT WAS OBSERVED THAT THE SLEEVE PROG WAS OVER BENT, AND THE SCREWDRIVER SHAFT TIP WAS TWISTED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) OUTER SLEEVE F/3.5 LCP PERC INST SYS THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583582 ↗
• MalfunctionJul 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION OF THE METRO OFFICE INVENTORY, IT WAS OBSERVED THAT THE SLEEVE PROG WAS OVER BENT, AND THE SCREWDRIVER SHAFT TIP WAS TWISTED. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266078 ↗
• MalfunctionNov 22, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE CHECKING THE SLEEVE FOR PERCUTANEOUS INSTRUMENTS, ONE OF THEM DID NOT DISENGAGE FROM THE AIMING ARM EASILY. IT WAS DIFFICULT TO REMOVE. THE WING SEEMED TO BE BENT INWARD. IT WAS FINALLY ABLE TO BE REMOVED. THERE WERE NO ISSUES WITH THE AIMING ARM, AND THERE WAS NO PATIENT INVOLVEMENT OR HOSPITAL INVOLVEMENT. THIS WAS JUST A GENERAL INSTRUMENT CHECK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849353 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THAT SLEEVE WAS BROKEN FROM AIMING ARM. SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAYED. NO PATIENT CONSEQUENCES DUE TO THIS EVENT. THIS REPORT IS FOR (1) OUTER SLEEVE F/3.5 LCP PERC INST SYS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14755950 ↗
• MalfunctionSep 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A ORIF DISTAL TIBIA PROCEDURE. THE SURGEON NOTICED THAT THE SLEEVES WERE LOOSE IN THE AIMING ARM. AFTER INSPECTION, ALL THREE SLEEVES WITH THE SAME LOT NUMBER WERE LOOSE IN THE AIMING ARM WHILE OTHERS FIT WELL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNK - GUIDES/SLEEVES/ AIMING: AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516276 ↗
• MalfunctionSep 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A ORIF DISTAL TIBIA PROCEDURE. THE SURGEON NOTICED THAT THE SLEEVES WERE LOOSE IN THE AIMING ARM. AFTER INSPECTION, ALL THREE SLEEVES WITH THE SAME LOT NUMBER WERE LOOSE IN THE AIMING ARM WHILE OTHERS FIT WELL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNK: GUIDES/SLEEVES/AIMING: AIMING ARM(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516271 ↗
• MalfunctionSep 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A ORIF DISTAL TIBIA PROCEDURE. THE SURGEON NOTICED THAT THE SLEEVES WERE LOOSE IN THE AIMING ARM. AFTER INSPECTION, ALL THREE SLEEVES WITH THE SAME LOT NUMBER WERE LOOSE IN THE AIMING ARM WHILE OTHERS FIT WELL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR ONE (1) OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516250 ↗