CHIMAERA Hip Fracture System 1 (REF 99-T932340R)Recalls & reported problems
Orthofix Srl · CHIMAERA HFS LONG NAIL RIGHT 125° L340MM D11MM STERILE · Class 2 · Implant
All models of CHIMAERA Hip Fracture System (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18054242514435), received between Apr 27, 2020 and Apr 27, 2020 — 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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2020Break; Break
THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 99-T932340R (CHIMAERA HFS LONG NAIL RIGHT 125 ° L340MM D11MM STERILE) - BATCH NUMBER: B1010983 - QUANTITY: 1 - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2020 - BODY PART TO WHICH DEVICE WAS APPLIED: RIGHT FEMUR - SURGERY DESCRIPTION: FRACTURE TREATMENT - PATIENT'S INFORMATION: (B)(6). - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: OTHER, SEE EVENT DESCRIPTION - EVENT DESCRIPTION: "BREAKAGE OF THE UPPER END OF THE NAIL. NECESSITY OF 2ND OPERATION WITH REDUCTION AND INTRAMEDULLARY NAIL FIXATION". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION, LOSS OF ACHIEVED CORRECTION) - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE - AN ADDITIONAL SURGERY WAS REQUIRED (PERFORMED ON (B)(6) 2020) - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED (PERFORMED ON (B)(6) 2020) - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAY IMAGES ARE AVAILABLE - PRODUCT IS AVAILABLE FOR RETU
Patient problems: No Code Available
MAUDE report 10000665 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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