LCP 03.123.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982074942), received between Aug 17, 2018 and May 1, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING DEVICE WAS MISSING A SCREW. INSTRUMENT IS A TWO PART AND CANNOT FUNCTION WITHOUT THE SCREW. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. PATIENT STATUS/ OUTCOME / CONSEQUENCES: WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST: TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942096 ↗
• MalfunctionSep 12, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON UNKNOWN DATE, POST OP INSPECTION WAS THAT SCREWDRIVERS WERE WARPED FROM USAGE. TROCAR WAS BENT AT THE ENDS, AND AIMING ARM HAD A CRACK POST OP INSPECTION. NO PATIENT CONSEQUENCES WAS THERE. THIS REPORT IS FOR ONE (1) THIS IS REPORT 2 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405948 ↗
• MalfunctionAug 17, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, INSERTION GUIDE SCREW, FOR THE LOCKING COMPRESSION PLATE (LCP) PERIARTICULAR PROXIMAL HUMERUS PLATE BROKE. IT WAS UNKNOWN IF THERE WAS A PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/LT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794718 ↗