CHIMAERA Hip Fracture System 1 (REF 99-T93700)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 18054242514763), received between Oct 3, 2017 and Jun 19, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2019Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 99-T93700 (CHIMAERA HFS LAG SCREW SLIDING L100MM STERILE) & 99-T93705 (CHIMAERA HFS LAG SCREW SLIDING L105MM STERILE) - MFR REPORTS 9680825-2019-00040 AND 00041 RESPECTIVELY. BATCH NUMBER: B1277461 & B1277606; QUANTITY: 1 EACH; HOSPITAL NAME: (B)(6); SURGEON NAME: DR (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2019; BODY PART TO WHICH DEVICE WAS APPLIED: CHIMAERA NAIL; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: (B)(6) YEARS, FEMALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: THE LOCKING MECHANISM OF THE LAG SCREWS DID NOT WORK INTRAOPERATIVE. THE SURGEON TRIED TO PUT THE LAG SCREWS IN A SECOND TIME THEN SOMETHING BROKE FROM THE LOCKING MECHANISM OF THE LAG SCREWS. THE COMPLAINT REPORT FORM ALSO INDICATES: THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITION: NO RESPONSE; NOTE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8710871 ↗
• InjuryOct 3, 2017Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2017. BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT'S INFORMATION: (B)(6), MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. EVENT DESCRIPTION: "PROBLEM OCCURRED DURING IMPLANT OF A CHIMAERA SHORT NAIL, FOR THE TREATMENT OF A FEMORAL PROXIMAL FRACTURE. THE PROBLEM OCCURRED WHEN THE SURGEON INSERTED THE CEPHALIC LAG SCREW SLIDING, ACCORDING TO THE FOLLOWING STEPS: POSITIONING OF THE CEPHALIC LAG SCREW TISSUE GUIDE AT 130° E AND INSERTION OF THE TROCAR IN THE TISSUE GUIDE; INCISION AND ADVANCE OF TISSUE GUIDE AND TROCAR TO THE BONE; INSERTION OF THE CEPHALIC GUIDE WIRE 3.2 MM WITH POWER DRILL; MEASURING ON THE WIRE OF THE SCREW LENGTH (IN THIS CASE, 105 MM); BASED ON SURGEON REQUEST, INSERTION OF A CEPHALIC LAG SCREW SLIDING, LENGTH 100 MM (AND NOT 105 MM); USE OF THE LAG SCREW GRADUAL REAMER SET UP AT 100 MM; INSERTION OF THE CEPHALIC SCREW. THE LATTER STEP EVIDENCED AN ANOMALY: THE SCREW ENGAGED THE NAIL, BUT THE SELF-LOCKING MECHANISM OF THE BLUE SCREWDRIVER DID NOT WORK. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6909973 ↗