MAUDE Adverse Event Report: LIFE SPINE LIFE SPINE; ADJUSTABLE DRILL

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

During surgery, the drill bit bent and when trying to back out the drill bit the tip broke off and was retained in the patient.It is important to note that the patient had existing spinal hardware that the drill bit could have come in contact with to cause the drill bit to bend.

Event Description

It was reported that during surgery, the drill bit bent in use and when the surgeon tried to back the drill bit out that the drill bit broke off and was retained in the patient.The patient did have existing spinal hardware in the near vicinity that could have caused the drill bit to bend.

• Brand Name: LIFE SPINE
• Type of Device: ADJUSTABLE DRILL
• Manufacturer (Section D): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 7470420
• MDR Text Key: 106972033
• Report Number: 3004499989-2018-00003
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other