NA 04.130.009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982112262), received between Jan 29, 2024 and Jan 29, 2024 — 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 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.

• MalfunctionJan 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF FOR FIFTH METACARPAL DIAPHYSEAL FRACTURE. THE LOCKING SCREW WAS INSERTED BUT UNLOCKED IN A HOLE IN THE Y-SHAPED PLATE. AND THEN, THE LOCKING SCREW IN QUESTION WAS TRIED TO BE INSERTED TO ANOTHER HOLE, AND UNLOCKED SITUATION REMAINED. MEANWHILE, THE UNFITTING HOLE WAS REATTEMPTED TO BE INSERTED BY OTHER SCREW, AND LOCKING WAS SUCCESSFUL. THE SURGEON COMMENTED THAT THE CAUSE FOR THE UNLOCKED SITUATION IS LIKELY THE SCREW IN QUESTION ITSELF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS, STABLE. NO FURTHER INFORMATION IS AVAILABLE. 2 ITEMS HAS BEEN REGISTERED AS IMPACTED PRODUCTS FOR THE SCREWS. THIS IS BECAUSE IT IS UNCLEAR WHICH LOT OF SCREWS IS THE ACTUAL COMPLAINT ITEM. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS WITH IMPLANT FIXATION DUE TO THE USE OF AN ALTERNATIVE. THIS REPORT IS FOR ONE (1)CORTSCR ø1.3 SELF-TAP L9 TAN. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596324 ↗