MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF MIDLINE BALL JOINT SCREWDRIVER

Model Number IN231/1

Device Problem Sharp Edges (4013)

Patient Problem Perforation of Vessels (2135)

Event Date 01/10/2019

Event Type  Injury  

Manufacturer Narrative

Review of the instrument dhr did not find any anomolies which may have contributed to the event.This instrumentation lot was inspected and found to be within specifications with required inspection data and certifications present and correct.Review of the risk documentation for this instrument was found to be within allowable limits.The rate of occurence was found to be less than remote, and the risk acceptable through the controlling factors identified in the device risk assessment.

Event Description

Complaint received (b)(6) 2019 indicating the following: during an alif procedure for the l4/5 disc space, a vessel was struck with a stalif midline ball joint screwdriver.The screwdriver was being used to place the second of three screws to secure a midline ii-ti intervertebral fusion device with integrated fixation.The vessel was repaired intra-operatively.The fusion constructed was completed with all 3 stalif midline screws being placed.The patient was then sent to recovery.To ensure patient safety, the patient underwent a second surgery later the same day (b)(6) 2019).The surgery was performed by the facility's vascular team to verify the repair.The vascular team determined that an arterial graft was needed to address the vessel injury.The surgeon indicated that the screwdriver had a sharp edge around the ball joint shroud, and that this was a factor in the vessel injury.

• Brand Name: STALIF MIDLINE BALL JOINT SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• Manufacturer (Section G): ELITE MEDICAL; 8415 wolf lake drive; bartlette TN 38133
• Manufacturer Contact: jason smith ; 900 airport rd, suite 3b; west chester, PA 19380
• MDR Report Key: 8866534
• MDR Text Key: 153547430
• Report Number: 3007494564-2019-00001
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2019

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: IN231/1
• Device Lot Number: 2014-514
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• 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): Required Intervention