NA 355.399SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982194961), received between May 18, 2020 and May 18, 2020 — classified as 1 injury.

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.

• InjuryMay 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING REMOVAL OF PROXIMAL FEMORAL NAILING SYSTEM (TFNA) LONG NAIL AND THE TITANIUM HELICAL BLADE, THE SURGEON REMOVED ONE (1) DISTAL INTERLOCK 5.0MM LOCKING SCREW AND PUT EXTRACTION INSTRUMENT ON THE HELICAL BLADE THEY THEN CONNECTED THE EXTRACTION BOLT TO THE PROXIMAL INSTRUMENTED END OF THE TFNA REMOVED THE HELICAL BLADE. THEY EXTRACTED THE BROKEN PROXIMAL END THEN PROCEEDED TO ATTEMPT TO REMOVE THE DISTAL BROKEN PORTION OF THE TFNA NAIL WITH AN EXTRACTION HOOK WITH NO SUCCESS FOR 2-3 HOURS. THEN MOVED TO THE DISTAL FEMUR TO MAKE AN OPENING HOLE DISTAL TO THE NAIL SO THEY CAN DRIVE OUT THE NAIL FROM THE DISTAL (RETROGRADE) END. THEY PROCEEDED IN DRIVING THE NAIL UNTIL THE INSTRUMENTED PROXIMAL PORTION OF THE NAIL WAS EXPOSED OUTSIDE OF THE SOFT TISSUE. THEY PUT THE EXTRACTION HOOK BACK INTO THE NAIL AND PULLED IT COMPLETELY OUT. IT IS UNKNOWN THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS GOOD. THIS (B)(4) CAPTURES THE INTRAOPERATIVE EVENT THAT DURING REMOVAL THERE WAS AN ADDITIONAL INTERVENTION THAT WAS REQUIRED TO REMOVE NAIL WHILE, THIS (B)(4) CAPTURES THE OPS-OPERATIVE EVENT THAT THE BROKEN P

  Patient problems: No Code Available; Not Applicable

  MAUDE report 10067265 ↗