MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.10.10.130

Device Problem Device Issue (2379)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

To date we did not received the piece for investigation.The lot number of the device is unknown at this time.

Event Description

After trial reduction the surgeon was unable to engage the broach with the offset broach handle.When the surgeon pushed with the retractor the femur fractured.The surgeon was finally able to remove the broach and to complete the surgery with a stem size 7 and a femur cerclage.The event delayed the surgery at least 1 hour.

• Brand Name: HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• 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, 6874 ; SZ 6874
• MDR Report Key: 7288832
• MDR Text Key: 100693234
• Report Number: 3005180920-2018-00077
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 01.10.10.130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other