LCP 03.113.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982072795), received between Apr 5, 2024 and Apr 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT UNKNOWN SURGERY WITH A PHILOS MIPO DEVICE. WHILE PERFORMING INTERNAL FIXATION, IN A DRILL SLEEVE, DRILL BIT BROKE OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN EXTRA 30 MINUTES. POSTOPERATIVE X-RAY CONFIRMED THERE WAS NO RESIDUE IN PATIENT¿S BODY. ACCORDING TO OPERATOR, THE DRILL WAS PULLED OFF TOWARD STANDARD ROTATION DEPENDING ON IT TOOK EXTRA FORCE, ACCORDINGLY ITS BIT WAS LIKELY STUCK IN SLIT IN SLEEVE, SO THE CONDITIONS LIKELY WAS BLAME. OUR SALES REP CONVINCED THE GRIEVANCE WHICH STEMMED FROM SURGEON¿S POOR TECHNIQUE. ADDITIONALLY, BROKEN BIT WAS REPORTED AS STILL TIGHTLY GETS STUCK IN SLEEVE, AND TAKING IT AWAY APPEARED TO BE HARD. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) DRILLSL Ø2.5 F/NEUTRAL POSITION PRECUT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055360 ↗