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ORTHOFIX CHIMAERA HIP FRACTURE SYSTEM - TROCHANTERIC NAILING SYSTEM 1 (REF 99-T93030)Recalls & reported problems

Orthofix Srl · CHIMAERA HFS SHORT NAIL 130° L180MM D10MM STERILE · Class 2 · Implant

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 18032937169894), received between Oct 15, 2018 and Oct 15, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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

  • Mechanical Problem1

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.

  • InjuryOct 15, 2018Mechanical Problem; Mechanical Problem

    THE INFORMATION PROVIDED BY THE SALES MANAGER INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING TREATMENT; EVENT DESCRIPTION: FOLLOWING A FALL ON (B)(6), PATIENT RETURNED TO THE HOSPITAL FOR A CHECK. FROM THE RADIOGRAPHIC CONTROL (POST FALL) THE NAIL POSITION DID NOT CHANGE, BUT AFTER 10 DAYS FROM FALL IT WAS EVIDENCED THE SLIPPAGE OF THE CEPHALIC SCREW. THE SCREW "DISCONNECTED" FROM THE NAIL. THE PATIENT WILL HAVE TO UNDERGO AN ADDITIONAL SURGERY TO REMOVE THE NAIL. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH THE DEVICE. FOLLOWING THE DEVICE FAILURE IT WAS NECESSARY AN ADDITIONAL SURGERY: REMOVAL OF THE NAIL PERFORMED ON (B)(6) 2018. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE: ORTHOFIX (B)(4) RECEIVED X-RAYS TAKEN BEFORE SURGERY, AFTER SURGERY, AFTER 10 DAYS FROM PATIENT FALL. PATIENT CURRENT HEALTH CONDITION: N

    Patient problems: No Code Available

    MAUDE report 7964304 ↗

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Sources and updates

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