NA 02.130.211Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982044655), received between Nov 12, 2018 and Apr 1, 2020 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 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 2 SCREWS WHICH THE VARIABLE ANGLE LOCKING SCREWS WERE TRIED IN THE SAME COMPROMISED HOLE OF VARIABLE ANGLE STRUT PLATE. WHILE, THE 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 10 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS AND OUTCOME WERE SUCCESSFUL AFTER AN ALTERNATIVE PLATE WAS USED. THIS COMPLAINT INVOLVES 6 DEVICES. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9913249 ↗
• MalfunctionJun 14, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING FRACTURED METACARPAL PROCEDURE, THE VARIABLE ANGLE LOCKING SCREW WOULD NOT LOCK TO THE PLATE. THE SCREW WAS SET ASIDE AND THE SURGEON CHOSE ANOTHER SCREW OF THE SAME SIZE TO LOCK THE PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS SUCCESSFUL. CONCOMITANT DEVICE REPORTED: PLATE (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701655 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, SURGEON WAS ATTEMPTING TO REMOVE A VARIABLE ANGLE (VA) LOCKING SCREW. AS THE VA LOCKING SCREW WAS BEING BACKED OUT, IT TWISTED AND THEN BROKE. THIS REPORT IS FOR ONE (1) 1.5MM VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060538 ↗