MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 3925.02

Device Problem Break (1069)

Patient Problems Weakness (2145); Brain Injury (2219); Alteration In Body Temperature (2682)

Event Date 09/18/2018

Event Type  Injury  

Event Description

During a procedure to remove spinal hardware, the rod cutter broke and impaled the patient's dura, creating a 2 cm tear and potentially traumatizing the cauda equina.Post-procedure, the patient was noted to have diminished strength in her lower extremities which is being monitored.

• Brand Name: ZIMMER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 7968899
• MDR Text Key: 123851014
• Report Number: 7968899
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 3925.02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27375 DA
• Patient Weight: 81