NA 207.764Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982148612), received between Feb 13, 2020 and Sep 12, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022 WHILE A SURGEON WAS INSERTING A CANNULATED SCREW, THE END OF THE SCREW BROKE OFF INSIDE OF THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT INVOLVES ONE 4.0MM CANNULATED SCREW-LONG THREAD 64MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402937 ↗
• MalfunctionFeb 13, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN ELBOW OPEN REDUCTION INTERNAL FIXATION (ORIF) (LATERAL CONDYLE) PROCEDURE THE THREAD OF THE CANNULATED SCREW STRIPPED OFF THE SCREW. AS THE SCREW WAS BEING ADVANCED INTO THE DISTAL HUMERUS INTO A PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENTS (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW-LONG THREAD 64MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706008 ↗