CHIMAERA Hip Fracture System 1 (REF 193973)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242515692), received between Apr 20, 2017 and Jul 18, 2019 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2019Break; Break

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON THAT COMPLETED THE COMPLAINT FORM: DR. (B)(6). DATE OF INITIAL SURGERY: ON (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: N/A. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 82 YEAR-OLD, FEMALE, WEIGHT 80 KG, PREVIOUS HEALTH CONDITION: ACCEPTABLE. PROBLEM OBSERVED DURING: INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: WHILE DRILLING (AS SHOWN IN THE SURGICAL MANUAL), THE CORTICAL DRILL BROKE OFF. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL. PROCEDURE: 20 MINUTES. AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE AVAILABLE (NOT RECEIVED). COPIES OF THE X-RAY IMAGES: "WE WILL ASK". PATIENT'S CURRENT HEALTH CONDITION: GOOD CONDITION. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 26 JUNE 2019: DATE OF SURGERY: ON (B)(6) 2019. LOCATION: FEMUR RIGHT

  Patient problems: No Code Available

  MAUDE report 8801392 ↗
• MalfunctionApr 20, 2017Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - DEVICE CODE: 193973 (4MM CORTICAL DRILL); - BATCH NUMBER: V1430079 (LOT LASER MARKED ON THE COMPONENT: V1429269); - QUANTITY: 1; - HOSPITAL NAME: (B)(6); - SURGEON'S NAME: DR. (B)(6); - DATE OF SURGERY: (B)(6) 2017; - BODY PART TO WHICH DEVICE WAS APPLIED: PROXIMAL FEMUR; - SURGERY DESCRIPTION: FRACTURE TREATMENT; - PATIENT INFORMATION: NOT PROVIDED; - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; - TYPE OF PROBLEM: OTHER; - EVENT DESCRIPTION: "DURING DRILLING WITH 193973 THE TIP BROKE. IT WAS REMOVED EASILY AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT MASSIVE EXTRA TIME". THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; - THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; - AN ADDITIONAL SURGERY WAS NOT REQUIRED; - A MEDICAL INTERVENTION WAS NOT REQUIRED; - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; - PATIENT CURRENT HEALTH CONDITION: OK. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6506826 ↗