NA 04.130.268SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982113238), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 malfunction.

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

• MalfunctionFeb 22, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO (2) OF THE DISTAL HOLES ON THE TITANIUM METACARPAL NECK PLATE DID NOT SEEM TO WORK DURING AN OPEN REDUCTION INTERNAL FIXATION OF THE FIFTH (5TH) METACARPAL. THE SURGEON THOUGHT IT WAS DEFECTIVE SINCE THE SCREW WOULD ONLY SPIN, AND NOT ATTACH INTO THE PLATE TO LOCK. THERE WAS A SURGICAL DELAY OF FIVE TO TEN (5-10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN); UNKNOWN MODULAR HAND (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 1.5MM TI VAL METACARPAL NECK PLATE-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361466 ↗