NA 291.13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982180186), received between Feb 19, 2026 and Feb 19, 2026 — classified as 1 injury.

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 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.

• InjuryFeb 19, 2026Break

  IT WAS REPORTED THAT COIL W/CERCL-WIRE Ø1.5 L10M SST WAS BROKEN PREMATURELY DURING INTRAOPERATIVE USE IN FRANCE, RESULTING IN ABNORMAL FRAGILITY. THE EVENT OCCURRED DURING PERIPROSTHETIC FRACTURE MANAGEMENT WITH OSTEOSYNTHESIS AND CERCLAGE. THE IMMEDIATE CONSEQUENCE WAS THE NEED TO REPEAT PASSAGE UNDER THE FEMUR TO RE-PASS THE WIRE, WHICH INCREASED THE RISK OF BLEEDING. THERE WERE CONCERNS ABOUT THE DURABILITY OF THE WIRE IN SITU AND THE POTENTIAL RISK OF LOOSENING BEFORE BONE CONSOLIDATION. A WIRE WAS DROPPED ON IRRECOVERABLE STRANDS, PROMPTING A CHANGE IN THE PASSAGE TECHNIQUE. SUBSEQUENTLY, PERSISTENT SEPSIS OF THE LEFT HIP DEVELOPED, ACCOMPANIED BY AN INFLAMMATORY SYNDROME AND RESURGENCE OF PAIN AT THE SURGICAL SITE. THE WIRES WERE REMOVED DURING A LATER OPERATION WITHOUT INCIDENT. COMPLAINT (B)(4) ARE LINKED. (B)(4) RECORDS THE PROCEDURE ON (B)(6) 2025 (B)(4) RECORDS THE PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 24389659 ↗