NA 475.940Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982234612), received between Apr 5, 2018 and Apr 5, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 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.

• InjuryApr 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL OF A 4.0MM TITANIUM ELASTIC NAILL DUE TO THE DEVICE EXTRUDING INTO THE KNEE JOINT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH TWO (2) ELASTIC NAILS ON AN UNKNOWN DATE SOMETIME AROUND THE YEAR OF 2011. FOLLOWING THAT ORIGINAL PROCEDURE, THE PATIENT WAS TOLD TO HAVE BOTH OF THE DEVICES REMOVED FOR UNKNOWN REASONS. DURING THE (B)(6) 2018 PROCEDURE, ONE (1) OF THE TWO (2) ELASTIC NAILS WERE REMOVED (THE ONE EXTRUDING INTO THE KNEE) AND AN INCISION AND DRAINAGE (I&D) WAS PERFORMED ON THE KNEE JOINT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO REPORTED SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE OKAY FOLLOWING THE PROCEDURE. CONCOMITANT DEVICE REPORTED: ELASTIC NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.0MM TITANIUM ELASTIC NAIL 440MM. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7400778 ↗