NA 207.664Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982148353), received between May 3, 2021 and May 3, 2021 — 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.

• MalfunctionMay 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 2.7MM VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK INTO THE FOURTH MOST PROXIMAL HOLE OF THE 2.7MM/3.5MM VARIABLE ANGLE LCP POSTEROLATERAL DISTAL HUMERUS PLATES WITH LATERAL SUPPORT. BOTH IMPLANTS REMAINED IN THE PATIENT. THE 4.0MM CANNULATED SCREW SHORT AND 4.0MM CANNULATED SCREW SHORT THREAD 64MM WERE STRIPPED OR THE CANNULATED HEX SCREWDRIVER WAS STRIPPED. A SECOND SET FOR ANOTHER SCREWDRIVER WAS OPENED AND THE HANDLE BROKE. BOTH SCREWS REMAINED IN THE PATIENT. THERE WAS TEN (10) MINUTES OF SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT OUTCOME WAS GOOD. THIS REPORT INVOLVES ONE (1) 4.0MM CANNULATED SCREW-SHORT THREAD 64MM. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760375 ↗