NA 04.205.085Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982116437), received between Dec 16, 2022 and Dec 16, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionDec 16, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY FOR DISTAL FEMUR FRACTURE WITH THE PRODUCT IN QUESTION. THE SURGEON DECIDED TO REPLACE THE SCREW IN THE DISTAL 4TH HOLE AFTER IMPLANTATION WAS COMPLETED AND CONFIRMED WITH AN IMAGE. WHEN HE PULLED OUT THE SCREW HE USED THE ELECTRIC SCREWDRIVER, HE MISTAKENLY TURNED THE POWER IN FORWARD ROTATION TO FIX THE SCREW TO THE PLATE. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO REMOVE IT WITH A SCREWDRIVER, BUT THE SCREW HOLE WAS STRIPPED, AND THE EXTRACTION WAS ABANDONED AND THE WOUND WAS CLOSED. THE SURGEON HAS CONFIRMED BY X-RAY THAT THERE ARE NO BROKEN PIECES OR OTHER RESIDUALS IN THE BODY. PATIENT STATUS/ OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DETAIL: UNK - SCREWDRIVERS: TRAUMA, (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNK - PLATES: TRAUMA, (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) CANN-LOCKSCR ø5 L85 TAN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995602 ↗