NA 02.130.260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982044952), received between Mar 9, 2020 and Mar 9, 2020 — 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 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.

• MalfunctionMar 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION OF 3-4 METACARPALS ON LEFT HAND, THE SURGEON PUT IN TWO (2) SCREWS IN THE PLATE ON THE METACARPAL WITH NO ISSUE. THEN THE TWO (2) DRILL BIT BROKE AND THE BROKEN ENDS LODGED IN THE CANAL OF THE BONE. THE SURGEON WAS ABLE TO GET ONE BROKEN END OUT. HE COULD NOT RETRIEVE THE OTHER BROKEN DRILL BIT PIECE. THEN THE SURGEON HAD A SCREWDRIVER BLADE BREAK UPON INSERTING A SCREW. AND LATER HE HAD ANOTHER SCREW HEAD BREAK AS HE INSERTED THE SCREW. THERE WAS A DELAY OF SURGERY OF SIXTY (60) MINUTES AS THE SURGEON RETRIEVED BROKEN PIECES AND TRIED TO USE OTHER IMPLANTS TO COMPLETE THE SURGERY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS FOR REPORT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9808455 ↗