NA 02.130.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982044648), received between Apr 1, 2020 and Apr 1, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING OPEN REDUCTION INTERNAL FIXATION OF THE HAND, THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK IN THE VARIABLE ANGLE STRUT PLATE. THE SURGEON THEN HAD TO REMOVE THE PLATE AND CHOOSE A DIFFERENT PLATE TO COMPLETE THE SURGERY. THE TWO (2) SCREWS WHICH THE VARIABLE ANGLE LOCKING SCREWS WERE TRIED IN THE SAME COMPROMISED HOLE OF VARIABLE ANGLE STRUT PLATE. WHILE, THE THREE (3) OTHER SCREWS WERE WASTED AFTER THE SURGEON REQUESTED NEW SCREWS FOR THE NEW PLATE. THE SURGEON FELT THE SCREW HEADS WERE COMPROMISED AND DID NOT WANT TO DAMAGE THE NEW PLATE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AND OUTCOME WERE SUCCESSFUL AFTER AN ALTERNATIVE PLATE WAS USED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9913240 ↗
• MalfunctionApr 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON FEBRUARY 18, 2020, DURING OPEN REDUCTION INTERNAL FIXATION OF THE HAND, THE FIVE (5) VARIABLE ANGLE LOCKING SCREWS WOULD NOT LOCK IN THE VARIABLE ANGLE STRUT PLATE. THE SURGEON THEN HAD TO REMOVE THE PLATE AND CHOOSE A DIFFERENT PLATE TO COMPLETE THE SURGERY. THE TWO (2) SCREWS WHICH THE VARIABLE ANGLE LOCKING SCREWS WERE TRIED IN THE SAME COMPROMISED HOLE OF VARIABLE ANGLE STRUT PLATE. WHILE, THE THREE (3) OTHER SCREWS WERE WASTED AFTER THE SURGEON REQUESTED NEW SCREWS FOR THE NEW PLATE. THE SURGEON FELT THE SCREW HEADS WERE COMPROMISED AND DID NOT WANT TO DAMAGE THE NEW PLATE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AND OUTCOME WERE SUCCESSFUL AFTER AN ALTERNATIVE PLATE WAS USED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9913218 ↗