MAUDE Adverse Event Report: ZIMMER BIOMET SPINE SPINAL ROD CUTTER; INSTRUMENT MANUAL SURGICAL GENERAL USE

Model Number 00-3925-002-00

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2018

Event Type  Injury  

Event Description

The procedure was a posterior spinal fusion and instrumentation.The medical professional was using a bolt cutter to trim down a 6.0 chrome cobalt rod.The bolt cutter broke off into the patient.The fragment was retrieved.The x-ray taken in the operating room did not show any retained fragments.

• Brand Name: SPINAL ROD CUTTER
• Type of Device: INSTRUMENT MANUAL SURGICAL GENERAL USE
• Manufacturer (Section D): ZIMMER BIOMET SPINE; warsaw IN 46580
• MDR Report Key: 7718054
• MDR Text Key: 115155442
• Report Number: MW5078594
• Device Sequence Number: 0
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-3925-002-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention