NA 475.915Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982234513), received between May 30, 2017 and Dec 29, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryDec 29, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTIFIED THAT ROUTINE REMOVAL OF A 1.5MM TITANIUM ELASTIC NAIL WILL BE REMOVED FROM A CLAVICLE. NO ADVERSE EVENTS OR COMPLAINTS WERE REPORTED. THE PROCEDURE OUTCOME WAS UNKNOWN. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 1.5MM TI ELASTIC NAIL 300MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13110006 ↗
• InjuryMay 30, 2017Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CLAVICULAR FRACTURE WAS TREATED WITH A TITANIUM ELASTIC NAIL (TEN) WHICH BROKE POSTOPERATIVELY. THE BREAKAGE WAS DETECTED ON (B)(6) 2017. THE INITIAL IMPLANT SURGERY WAS ON (B)(6) 2017 AND THE REVISION SURGERY TOOK PLACE ON (B)(6) 2017. THIS REPORT IS FOR ONE (1) 1.5 MM ELASTIC NAIL. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6598146 ↗