MAUDE Adverse Event Report: SYNTHES SYNTHES; PROXIMAL FEMORAL NAILING SYSTEM

Model Number 03.037.022

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/14/2017

Event Type  Injury  

Event Description

Physician was performing an open reduction internal fixation of a hip fracture with synthes trochanteric fixation nail.Patient had a prior femur fracture with femoral nail placement.When reaming for the trochanteric nail placement, the 6mm reamer tip contacted the previously placed femur nail and splintered.Using an arthroscope and irrigation, the large pieces of the reamer were removed.Small flakes were determined to be more detrimental to the patient if removed.

• Brand Name: SYNTHES
• Type of Device: PROXIMAL FEMORAL NAILING SYSTEM
• Manufacturer (Section D): SYNTHES; irving TX 75063
• MDR Report Key: 7142073
• MDR Text Key: 95741855
• Report Number: MW5074176
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.037.022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 55