CHIMAERA Hip Fracture System 1 (REF 193337)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18056099649216), received between Feb 23, 2021 and Apr 20, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Mechanical Problem

  RECEIVED INFORMATION STATING THAT DURING REMOVAL OF A CHIMAERA IMPLANT, THE NAIL EXTRACTOR GOT CROSS THREADED IN THE LAG SCREW. IT WAS POSSIBLE TO FINALIZE THE SURGERY, WITH A DELAY OF 30 MINUTES. PATIENT/USER NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930307 ↗
• MalfunctionApr 17, 2026Mechanical Problem

  Received information stating that during removal of a chimaera implant, the nail extractor got cross threaded in the lag screw. It was possible to finalize the surgery, with a delay of 30 minutes.Patient/user not affected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909536 ↗
• InjuryDec 23, 2025Break; Break

  RECEIVED INFORMATION STATING THAT DURING THE REMOVAL OF A CHIMAERA NAIL, THE NAIL EXTRACTOR BROKE INSIDE THE CEPHALIC SCREW. THIS LED TO AN EXTENSION OF SURGERY TIME OF TWO HOURS.THE PATIENT WAS REPORTED IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875741 ↗
• InjuryFeb 23, 2021Break; Mechanical Problem; Break; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: PRODUCT CODE: (B)(4) (SCREW EXTRACTOR SIZE 4-9 MM), BATCH NUMBER: G190645, QUANTITY: 1, DATE OF SURGERY: (B)(6) 2020, BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR, SURGERY DESCRIPTION: FRACTURE TREATMENT, PATIENT'S INFORMATION:NOT APPLICABLE, PROBLEM OBSERVED DURING: ON SCHEDULED DEVICE REMOVAL, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: "CASE WAS FOR CHIMAERA REMOVAL: WE ASSUMED THE THREADING OF THE MAIN CHIMAERA LAG SCREW WAS DAMAGED AS THE NORMAL SCREW DRIVER COULD NOT ENGAGE INTO THE THREAD, THIS PROBABLY OCCURRED WHEN IT WAS INSERTED. THE SURGEON THEN HAD TO REVERT TO THE SCREW EXTRACTOR TOOL (193337) FOR REMOVAL OF THE MAIN LAG SCREW. AS THE EXTRACTION INSTRUMENT HAS A REVERSE THREAD INTERFACE, ENGAGING IT INTO THE LAG SCREW AND THEN ALSO DISENGAGING THE LAG SCREW FROM THE NAIL. THE PROBLEM WE FACE IS THAT ONCE THE SCREW IS REMOVED, THE SCREW CANNOT BE REMOVED FROM THE EXTRACTOR TOOL RESULTING IN A BROKEN TIP WHEN WE DO SO". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS - THE PATIENT WAS IN SURGERY FOR ALMOST 3

  Patient problems: Oversedation

  MAUDE report 11364101 ↗