MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA GENERAL BROACH; SURGICAL INSTRUMENT FOR HIP SURGERY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs manager: intraoperative femoral fractures are known possible adverse events of total hip replacements, described and quantified in literature.They mainly depend on bone morphology and mechanical properties.In this case, there is no reason to suspect a malfunctioning device.

Event Description

Durin a revision surgery (emdr 2019-00565) due to a small bone femur fracture, the surgeon started with the preparation of the femur with the broach and a distal fracture was generated.The surgeon switched to a revision stem and completed successfully the surgery.).

• Brand Name: QUADRA GENERAL BROACH
• Type of Device: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8784031
• MDR Text Key: 150809648
• Report Number: 3005180920-2019-00571
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100