VA-LCP 04.211.255SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982119988), received between Oct 3, 2022 and Oct 3, 2022 — 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 18, 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.

• MalfunctionOct 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE RIGHT FIFTH METATARSAL WITH THE SCREW. AFTER DRILLING WITH VA DRILL SLEEVE WHEN THE SURGEON TRIED TO INSERT THE SCREW WITH SCREWDRIVER, THE SCREW COULD NOT LOCKED. THE SURGEON COMMENTED THAT IT WAS POSSIBLE THAT THE SLEEVE DIDN¿T HOLD THE SCREW HOLE OF PLATE AND THE INSERTION ANGLE WAS OVER 15DEGREE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT IS LISTED AS STABLE. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1); UNK - SCREWDRIVERS (PART# 60.231.004; LOT# UNKNOWN; QUANTITY: 1). THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR A 2.4/2.7MM TI VA-LCP T-FUSION PL/2 HOLE HEAD/LONG-STER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527597 ↗